Data / Medical devices / United States / Osteomed
Osteomed: FDA-registered device maker in Addison, TX, United States, 61 510(k) clearances
Osteomed is registered with the FDA (registration 2027754) in Addison, TX, United States. It lists 59 device types. The FDA files 61 510(k) clearances under its listings, the newest dated February 24, 2021. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 2027754
- Address
- 3885 Arapaho Rd, Addison, TX, United States, 75001
- Owner or operator
- OSTEOMED (9000613)
- Roles
- Complaint file establishment, Contract manufacturer, Contract sterilizer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- October 2, 1992
- Registered through
- 2027
- Brand names listed
- Compressor Instrument, Cup Curette, Dental Burs, Goniometer, Ring Curette, Sharp Hook
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 24, 2021 | K203479 | ExtremiLOCK Lateral Ankle Fusion Plates | HRS | Substantially Equivalent | Osteomed | accessdata.fda.gov |
| October 29, 2020 | K202105 | OsteoMed ExtremiFix Mini & Small System Tray | KCT | Substantially Equivalent | Osteomed, LLC | accessdata.fda.gov |
| October 15, 2020 | K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw System | HWC | Substantially Equivalent | Osteomed, LLC | accessdata.fda.gov |
| May 19, 2017 | K162542 | OsteoMed PINNACLE Driver | HBE | Substantially Equivalent | Osteomed | accessdata.fda.gov |
| April 4, 2017 | K163303 | OsteoMed ExtremiFix Mid and Large Screw System | HWC | Substantially Equivalent | Osteomed, LLC | accessdata.fda.gov |
| April 4, 2017 | K162544 | OsteoMed PINNACLE Driver | KMW | Substantially Equivalent | Osteomed | accessdata.fda.gov |
| September 16, 2016 | K161568 | Bone Solutions Mixing and Delivery System | FMF | Substantially Equivalent | Bone Solutions, Inc. | accessdata.fda.gov |
| May 19, 2016 | K161041 | OsteoMed ExtremiLOCK Wrist Plating System | HRS | Substantially Equivalent | Osteomed | accessdata.fda.gov |
| December 21, 2015 | K152145 | OsteoMed ExtremiLOCK Wrist Plating System | HRS | Substantially Equivalent | Osteomed | accessdata.fda.gov |
| September 21, 2015 | K151195 | OsteoMed IMF Screw | DZL | Substantially Equivalent | Osteomed | accessdata.fda.gov |
| July 15, 2015 | K151021 | OsteoMed Cannulated Screw System | HWC | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| April 1, 2015 | K143338 | Argulated Locking Plates | JEY | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| December 18, 2014 | K140978 | OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM | JEY | Substantially Equivalent | Osteomed | accessdata.fda.gov |
| July 11, 2014 | K141550 | INSTAFIX SHAPE MEMORY FIXATION SYSTEM | JDR | Substantially Equivalent | Ot Medical | accessdata.fda.gov |
| February 28, 2014 | K140283 | OSTEOMED EXTREMIFUSE SYSTEM | HWC | Substantially Equivalent | Osteomed | accessdata.fda.gov |
| February 24, 2014 | K133691 | EXTRIMILOCK ANKLE PLATING SYSTEM | HRS | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| December 6, 2013 | K131851 | OSTEOMED NEURO RONGEUR | HAE | Substantially Equivalent | Osteomed | accessdata.fda.gov |
| December 2, 2013 | K133437 | 1ST MTP PLATE | HRS | Substantially Equivalent | Osteomed | accessdata.fda.gov |
| June 18, 2013 | K131445 | OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM | HRS | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| June 3, 2013 | K123885 | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR | PBJ | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| May 31, 2013 | K130412 | OSTEOMED EXTREMIFUSE SYSTEM | HWC | Substantially Equivalent | Osteomed | accessdata.fda.gov |
| October 7, 2011 | K111419 | OSTEOMED HAND FUSION SYSTEM | HRS | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| August 15, 2011 | K111176 | OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM | GWO | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| September 10, 2009 | K091614 | OSTEOMED FOOT PLATING SYSTEM | HRS | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| July 2, 2009 | K090522 | OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM | HRS | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| May 21, 2009 | K071004 | OSTEOCRETE BONE VOID FILLER | MQV | Substantially Equivalent | Bone Solutions, Inc. | accessdata.fda.gov |
| August 1, 2008 | K081876 | OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING | KWD | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| May 15, 2008 | K080694 | OSTEOMED MODULAR LOCKING FIXATION SYSTEM | JEY | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| August 15, 2007 | K071477 | REVERTO 55 AND 37 SHAPE MEMORY STAPLES | JDR | Substantially Equivalent | Core Essence Orthopaedics, LLC | accessdata.fda.gov |
| March 2, 2007 | K063298 | OSTEOMED HEADLESS CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| November 17, 2006 | K062851 | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED | MQN | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| October 31, 2006 | K062863 | OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| June 2, 2006 | K060536 | OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM | KWD | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| April 7, 2006 | K051798 | OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM | DZE | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| January 26, 2006 | K060026 | KOBY SURGICAL INTERNAL FIXATION SYSTEM | HWC | Substantially Equivalent | Koby Surgical | accessdata.fda.gov |
| February 10, 2005 | K043434 | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM | MQN | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| July 8, 2004 | K031701 | OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM | NEI | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| January 7, 2004 | K031936 | OSTEOMED ORTHODONTIC SCREW SYSTEM | DZE | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| November 3, 2003 | K031708 | OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM | MQN | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| August 22, 2003 | K031155 | OSTEOMED SUBTALAR IMPLANT SYSTEM | HWC | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| May 9, 2003 | K030448 | OSTEOMED 2.0 LOCKING PLATES AND SCREWS | JEY | Substantially Equivalent | Osteomed LP | accessdata.fda.gov |
| April 1, 2003 | K022277 | OSTEOMED CRANIAL FLAP FIXATION SYSTEM | GXN | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| November 26, 2002 | K022887 | INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | KWH | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| November 25, 2002 | K022886 | METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | KWH | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| October 18, 2002 | K023260 | 1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM | HWC | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| August 14, 2002 | K013618 | INTRAORAL MANDIBULAR DISTRACTION SYSTEM | MQN | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| August 8, 2002 | K021618 | OSA RIGID INTERNAL FIXATION SYSTEM | JEY | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| May 30, 2001 | K010783 | 2.0/2.4 CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| June 16, 1999 | K990944 | OSTEOMED INTRAORAL DISTRACTION SYSTEM | MQN | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| March 18, 1998 | K974785 | AUTO-DRIVE BONE SCREW | HWC | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| October 10, 1997 | K962774 | OSTEOMED QUICKFIX | DZL | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| June 27, 1997 | K971692 | OSTEOPOWER SYSTEM AND ACCESSORIES | KMW | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| November 14, 1996 | K963394 | OSTEOMED TRAM | JEY | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| October 25, 1996 | K961418 | OSTEOMED MSS | DZL | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| December 8, 1995 | K954330 | SUPER SCREW 3.5 MM | HWC | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| November 7, 1994 | K933101 | THE OSTEOMED B POWER SYSTEM AND ACCESSORIES | KIJ | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| November 9, 1993 | K922211 | OSTEOMED GREAT TOE SYSTEM | LZJ | Substantially Equivalent for Some Indications | Osteomed Corp. | accessdata.fda.gov |
| April 1, 1993 | K924018 | M3 LAG SCREW FIXATION SYSTEM | HWC | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| February 17, 1993 | K924138 | OSTEOMED M3 SYSTEM (SBF SYSTEM) | JEY | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| August 21, 1991 | K911936 | OSTEOMED SBF SYSTEM (SBF) | DZL | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
| June 10, 1991 | K911937 | OSTEOMED IB DRILL | EFB | Substantially Equivalent | Osteomed Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 31, 2023 | 92479 | Class II | Ongoing | REF:, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile | Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. | accessdata.fda.gov |
| October 28, 2021 | 88990 | Class II | Ongoing | OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console | Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient. | accessdata.fda.gov |
| April 2, 2020 | 85529 | Class II | Terminated | OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: /00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. | accessdata.fda.gov |
| June 7, 2011 | 59213 | Not yet classified | Terminated | OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001 | Two of the Implant Driver Assembly tips were reported to break during surgery. | accessdata.fda.gov |
Compare with other makers
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
- All makers of Hook, Bone
- All makers of Driver, Wire, And Bone Drill, Manual
- All makers of System, Image Processing, Radiological
- All makers of Plate, Bone
Updated July 7, 2023. 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.