Data / Medical devices / Germany / Stryker Leibinger GMBH & Co. KG
Stryker Leibinger GMBH & Co. KG: FDA-registered device maker in FREIBURG Baden-Wurttemberg, Germany, 122 510(k) clearances and 2 PMA approvals
Stryker Leibinger GMBH & Co. KG is registered with the FDA (registration 8010177) in FREIBURG Baden-Wurttemberg, Germany. It lists 77 device types. The FDA files 122 510(k) clearances and 2 PMA approvals under its listings, the newest dated July 31, 2026. 8 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 8010177
- FEI number
- 3002821504
- Address
- Botzinger Strasse 39-41, FREIBURG Baden-Wurttemberg, Germany, D-79111
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- June 9, 1986
- Registered through
- 2027
- Brand names listed
- 0250-070-500 Suction Irrigator 2, 0250-070-520 StrykeFlow 2 With Tip, 045 IN. (1.143mm) K-WIRE W/LENGTH MARKINGS, 1.2X10mm BONE SCREWSCROSSPINSELFT, 1.2X12mm BONE SCREWSCROSSPINSELFT, 1.2X14mm BONE SCREWSCROSSPINSELFT, 1.2X16mm BONE SCREWSCROSSPINSELFT, 1.2X18mm BONE SCREWSCROSSPINSELFT and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 122.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 2026 | K253655 | Angled Screwdriver MED (M-SD090) | DZI | Substantially Equivalent | W&H Dentalwerk Bürmoos GmbH | accessdata.fda.gov |
| July 1, 2026 | K261054 | RibPlate System | HRS | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| March 12, 2026 | K254233 | MEDPOR Customized Implant Kit | FWP | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| February 19, 2026 | K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| February 6, 2026 | K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| September 25, 2025 | K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer | OLO | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| December 11, 2024 | K243491 | SternalPlate Expansion | HRS | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| August 27, 2024 | K241517 | Q Guidance System; Mako Spine System; | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| July 25, 2024 | K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| July 12, 2024 | K240651 | MRI Universal | JEY | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| June 6, 2024 | K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| March 14, 2024 | K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| January 13, 2024 | K232350 | Stryker Facial iD System | JEY | Substantially Equivalent | Stryker Craniomaxillofacial | accessdata.fda.gov |
| August 24, 2023 | K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | DZL | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| August 14, 2023 | K231208 | Stryker Resorbable Fixation System | HBW | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| August 5, 2023 | K230733 | Stryker Resorbable Fixation System | JEY | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| February 16, 2023 | K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System | HAW | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| February 13, 2023 | K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| December 9, 2022 | K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | JEY | Substantially Equivalent | Stryker Craniomaxillofacial (Cmf) | accessdata.fda.gov |
| November 9, 2022 | K221855 | Universal CMF System | JEY | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| July 12, 2022 | K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | PGW | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| May 27, 2022 | K220593 | Spine Guidance Software, Stryker Q Guidance System | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| February 4, 2022 | K213777 | Stryker Resorbable Fixation System | JEY | Substantially Equivalent | Stryker Leibinger Micro Implants | accessdata.fda.gov |
| May 11, 2021 | K203228 | DART-FIRE EDGE Cannulated Screw System | HWC | Substantially Equivalent | Wright Medical | accessdata.fda.gov |
| February 9, 2021 | K203055 | Stryker PEEK Customized Cranial Implant Kit | GWO | Substantially Equivalent | Stryker | accessdata.fda.gov |
| October 9, 2020 | K202609 | Instrument Clamps Electromagnetic | PGW | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| March 26, 2020 | K193143 | Stryker Facial iD Plating System | JEY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| March 26, 2020 | K193136 | Stryker Customized Mandible Recon Plate Kit | JEY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| August 15, 2019 | K191916 | Stryker CMF MEDPOR Priority Customized Implant Kit | FWP | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| July 11, 2019 | K190229 | Stryker PEEK Customized Cranial Implant Kit | GWO | Substantially Equivalent | Stryker | accessdata.fda.gov |
| July 8, 2019 | K190286 | Materialise Glenoid Positioning System | KWS | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| June 28, 2019 | K190696 | Stryker Surgeon iD Mandible Recon Plate | JEY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| March 5, 2019 | K183172 | Stryker SternalPlate System | HRS | Substantially Equivalent | Stryker | accessdata.fda.gov |
| February 14, 2019 | K183196 | Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker | OLO | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| January 7, 2019 | K182305 | Stryker Facial iD Plating System | JEY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| November 6, 2018 | K182425 | Universal Mesh - Sterile | GWO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| September 11, 2018 | K181504 | Stryker Pediatric Mandibular Distractor 2 | MQN | Substantially Equivalent | Stryker | accessdata.fda.gov |
| April 18, 2018 | K173615 | Stryker Universal Select Sterilization Tray System | KCT | Substantially Equivalent | Paragon Medical | accessdata.fda.gov |
| November 13, 2017 | K170725 | Stryker Universal Mesh | GWO | Substantially Equivalent | Stryker | accessdata.fda.gov |
| November 8, 2017 | K170773 | Stryker Universal Mesh | JEY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| October 31, 2017 | K172572 | Stryker Upper-Face AXS screws and Mid-Face AXS screws | JEY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| October 18, 2017 | K172034 | Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap | OLO | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| September 27, 2017 | K171661 | Scopis Extended Instrument Set EM | PGW | Substantially Equivalent | Scopis GmbH | accessdata.fda.gov |
| July 24, 2017 | K171364 | MP LeFort I Plates | JEY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| May 19, 2017 | K171152 | Stryker Universal Neuro III System AXS Screw | HBW | Substantially Equivalent | Stryker | accessdata.fda.gov |
| February 23, 2017 | K162937 | Stryker OrthoMap Versatile Hip System | OLO | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| February 22, 2017 | K162929 | Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker | HAW | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| February 9, 2017 | K161491 | Scopis Hybrid Navigation System EM | PGW | Substantially Equivalent | Scopis GmbH | accessdata.fda.gov |
| December 8, 2016 | K161821 | Stryker Universal Mesh | GWO | Substantially Equivalent | Stryker | accessdata.fda.gov |
| October 12, 2016 | K162341 | Stryker OrthoMap Precision Knee system | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| July 7, 2016 | K153240 | Styrker OrthoMap Express Knee System | OLO | Substantially Equivalent | Stryker Corporate | accessdata.fda.gov |
| March 10, 2016 | K153248 | PEEK Customized Cranial Implant | GWO | Substantially Equivalent | Stryker | accessdata.fda.gov |
| February 5, 2016 | K153508 | Stryker CMF MEDPOR Customized Implant | FWP | Substantially Equivalent | Stryker | accessdata.fda.gov |
| September 4, 2015 | K143597 | Navigated XIA 4.5 Polyaxial Screwdriver | OLO | Substantially Equivalent | Stryker Corporate | accessdata.fda.gov |
| September 2, 2015 | K143661 | DirectInject | GXP | Substantially Equivalent | Stryker | accessdata.fda.gov |
| August 26, 2015 | K152076 | PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority | GWO | Substantially Equivalent | Stryker | accessdata.fda.gov |
| July 8, 2015 | K150301 | NavSuite3 Kit | HAW | Substantially Equivalent | Stryker Leibinger GmbH & Co. KG - Navigation | accessdata.fda.gov |
| June 24, 2015 | K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade | HBW | Substantially Equivalent | Stryker | accessdata.fda.gov |
| May 5, 2015 | K142568 | Stryker MEDPOR TITAN 3D Orbital Floor Implant | JEY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| March 23, 2015 | K143173 | Stryker CMF MEDPOR Customized Implant | FWP | Substantially Equivalent | Stryker | accessdata.fda.gov |
| October 31, 2014 | K141941 | SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D | OLO | Substantially Equivalent | Stryker Corporate | accessdata.fda.gov |
| September 8, 2014 | K141551 | PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) | PGW | Substantially Equivalent | Stryker Corporate | accessdata.fda.gov |
| August 1, 2014 | K133461 | STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM | JEY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| April 9, 2014 | K133285 | STRYKER TEMPORARY CONDYLAR PROSTHESIS | NEI | Substantially Equivalent | Stryker | accessdata.fda.gov |
| January 9, 2014 | K121235 | LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM | JEY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| December 6, 2013 | K132519 | STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT | JEY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| October 18, 2013 | K131214 | CRANIAL MAP NEURO | HAW | Substantially Equivalent | Stryker Corporate | accessdata.fda.gov |
| October 17, 2013 | K131775 | UNIVERSAL NEURO 3 SYSTEM | GWO | Substantially Equivalent | Stryker | accessdata.fda.gov |
| September 27, 2013 | K130874 | STRYKER NAV3I PLATFORM | HAW | Substantially Equivalent | Stryker Corporate | accessdata.fda.gov |
| April 9, 2013 | K123786 | STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM | JEY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| November 1, 2012 | K121315 | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT | FWP | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| October 31, 2012 | K122313 | STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM | JEY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| September 14, 2012 | K121153 | PEEK CUSTOMIZED CRAIAL IMPLANT KIT | GWO | Substantially Equivalent | Stryker | accessdata.fda.gov |
| June 11, 2012 | K120352 | STRYKER QUIKFLAP STERILE PROCEDURE PACK | GWO | Substantially Equivalent | Stryker | accessdata.fda.gov |
| January 5, 2012 | K112557 | STRYKER UNIVERSAL NEURO 3 SYSTEM | GWO | Substantially Equivalent | Stryker | accessdata.fda.gov |
| December 23, 2011 | K113109 | STRYKER RESORBABLE FIXATION SYSTEM | HRS | Substantially Equivalent | Stryker | accessdata.fda.gov |
| March 7, 2011 | K103400 | FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP | OLO | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| January 7, 2011 | K102184 | MEDPOR CONTAIN CAN IMPLANT | NPK | Substantially Equivalent | Porex Surgical, Inc. | accessdata.fda.gov |
| August 4, 2010 | K093206 | ORTHOMAP 3D 1.1 MODULE | OLO | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| March 19, 2010 | K091120 | MEDPOR CONTAIN IMPLANT | NPK | Substantially Equivalent | Porex Surgical, Inc. | accessdata.fda.gov |
| February 3, 2009 | K083621 | MEDPOR CUSTOMIZED SURGICAL IMPLANT | JOF | Substantially Equivalent | Porex Surgical, Inc. | accessdata.fda.gov |
| April 27, 2007 | K070876 | STRYKER TWIST DRILLS | HBE | Substantially Equivalent | Stryker Craniomaxillofacial | accessdata.fda.gov |
| December 14, 2006 | K062640 | STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 | HAW | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| September 22, 2006 | K060763 | STRYKER INJECTABLE CEMENT | GXP | Substantially Equivalent | Stryker | accessdata.fda.gov |
| August 5, 2005 | K052037 | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | Howmedica Osteonics Corp. | accessdata.fda.gov |
| March 17, 2005 | K050535 | STRYKER MMF SCREW | DZL | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| September 30, 2004 | K041651 | STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM | DZE | Substantially Equivalent | Stryker Leibinger | accessdata.fda.gov |
| July 16, 2004 | K040851 | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM | HPZ | Substantially Equivalent | Porex Surgical, Inc. | accessdata.fda.gov |
| June 30, 2004 | K040364 | MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH | FTM | Substantially Equivalent | Porex Surgical, Inc. | accessdata.fda.gov |
| February 25, 2004 | K033232 | COLORADO MICRODISSECTION NEEDLE | GEI | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| September 10, 2003 | K031659 | UNIVERSAL NEURO SYSTEM | JEY | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| June 2, 2003 | K022579 | STRYKER NAVIGATION SYSTEM-KNEE MODULE | HAW | Substantially Equivalent | Stryker Leibinger | accessdata.fda.gov |
| January 22, 2003 | K022365 | STRYKER NAVIGATION SYSTEM - HIP MODULE | HAW | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| December 17, 2002 | K022185 | UNIVERSAL CMF SYSTEM | JEY | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| August 5, 2002 | K021357 | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT | HPZ | Substantially Equivalent | Porex Surgical, Inc. | accessdata.fda.gov |
| March 8, 2002 | K014263 | NEWGEN/UNIVERSAL MANDIBULAR SYSTEM | JEY | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| December 3, 2001 | K012380 | MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY | HAW | Substantially Equivalent | Stryker Leibinger | accessdata.fda.gov |
| June 19, 2001 | K010902 | MEDPOR QUAD MOTILITY IMPLANT | HPZ | Substantially Equivalent | Porex Surgical, Inc. | accessdata.fda.gov |
| January 4, 2001 | K003111 | STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES | HAW | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| November 17, 2000 | K002586 | MEDPOR PTERIONAL SURGICAL IMPLANT | MNF | Substantially Equivalent | Porex Surgical Products Group | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 30, 2015 | P130014 | ADHERUS AUTOSPRAY DURAL SEALANT | NQR | 20 | July 15, 2026 | accessdata.fda.gov |
| July 2, 1999 | P980052 | TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS | LZD | 13 | March 6, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 24, 2026 | 99855 | Not yet classified | Open, Classified | Precision Pointer Electromagnetic (8000-050-001) | Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the device is inside the patient. | accessdata.fda.gov |
| April 4, 2024 | 94456 | Class II | Ongoing | 8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image gui | Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction. | accessdata.fda.gov |
| March 29, 2024 | 94367 | Class II | Ongoing | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614 | Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure | accessdata.fda.gov |
| December 6, 2022 | 91479 | Class II | Ongoing | Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis | Device was shipped without having regulatory approval. | accessdata.fda.gov |
| December 29, 2021 | 89458 | Class II | Terminated | MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 | Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side. | accessdata.fda.gov |
| April 1, 2021 | 87684 | Class II | Terminated | DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden | Inability for the user to inject the paste from the syringe into the target location. | accessdata.fda.gov |
| June 22, 2018 | 80371 | Class II | Terminated | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load b | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | accessdata.fda.gov |
| January 3, 2017 | 76146 | Class II | Terminated | QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System | An incorrect sterility status on the label, non-sterile products labeled as sterile | accessdata.fda.gov |
Compare with other makers
- All makers of Plate, Cranioplasty, Preformed, Alterable
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- All makers of Plate, Fixation, Bone
- All makers of Mesh, Surgical, Metal
- All makers of Driver, Wire, And Bone Drill, Manual
- All makers of Fastener, Fixation, Biodegradable, Soft Tissue
Updated October 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.