Data / Medical devices / United States / Zavation
Zavation: FDA-registered device maker in Flowood, MS, United States, 84 510(k) clearances
Zavation is registered with the FDA (registration 3008583793) in Flowood, MS, United States. It lists 47 device types. The FDA files 84 510(k) clearances under its listings, the newest dated February 3, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008583793
- Address
- 3670 Flowood Dr, Flowood, MS, United States, 39232
- Owner or operator
- Zavation Medical Products LLC (10055475)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 28, 2017
- Registered through
- 2026
- Brand names listed
- 11G Renova Spine Balloon Catheter/Kit; InterV Kyphoplasty Catheter (Flex)/Kit;, 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex), ACCESSORIES, FIXATION, SPINAL INTERVERTEBRAL BODY, APPLIANCE, FIXATION, SPINAL INTERLAMINAL, APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY, Ambassador Cervical Plate System, Atrion QL2530 Inflation Device, Awl and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | 1 | Complaint file establishment | accessdata.fda.gov |
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Bender | HXW | 1 | Complaint file establishment | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment | accessdata.fda.gov |
| Broach | HTQ | 1 | Complaint file establishment | accessdata.fda.gov |
| Caliper | KTZ | 1 | Complaint file establishment | accessdata.fda.gov |
| Cement, Bone, Vertebroplasty | NDN | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette | HTF | 1 | Complaint file establishment | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Complaint file establishment | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | 1 | Complaint file establishment | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Complaint file establishment | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Complaint file establishment | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mixer, Cement, For Clinical Use | JDZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Complaint file establishment | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Complaint file establishment | accessdata.fda.gov |
| Posterior Cervical Screw System | NKG | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Complaint file establishment | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Complaint file establishment | accessdata.fda.gov |
| Reamer | HTO | 1 | Complaint file establishment | accessdata.fda.gov |
| Rongeur | HTX | 1 | Complaint file establishment | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment | accessdata.fda.gov |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Spinal Vertebral Body Replacement Device | MQP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Spinous Process Plate | PEK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Facet Screw Spinal Device | MRW | U | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tamp | HXG | 1 | Complaint file establishment | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Complaint file establishment | accessdata.fda.gov |
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 3, 2025 | K243908 | Tiger 2 System | NKB | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| April 10, 2024 | K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System | MAX | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| December 8, 2023 | K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System | MAX | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| August 22, 2023 | K231811 | Zavation Connector System | NKB | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| June 14, 2023 | K230731 | Zavation ALIF System | OVD | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| June 6, 2023 | K230329 | F3D Interbody System | ODP | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| May 2, 2023 | K230880 | CoreLink Navigation Instruments | OLO | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| March 21, 2023 | K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | OUR | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| January 18, 2023 | K221726 | Uni-FuZe-C Bone Strip | MQV | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| December 5, 2022 | K222614 | Zavation Spinal System | NKB | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| August 12, 2022 | K221049 | Zavation VariSync Plate System and VariSync Spacer System | OVE | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| August 9, 2022 | K221776 | NextGen Pedicle Screw System | NKB | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| June 1, 2022 | K220973 | CoreLink Navigation Instruments | OLO | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| February 4, 2022 | K211417 | F3D-C2 Cervical Stand-Alone System | OVE | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| January 19, 2022 | K214059 | CoreLink Navigation Instruments | OLO | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| October 13, 2021 | K212825 | CoreLink Navigation Instruments | OLO | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| August 11, 2021 | K211993 | Z-LINKPC System | NKG | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| July 12, 2021 | K211113 | Zavation Spinal System | NKB | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| June 24, 2021 | K211306 | LABYRINTH | MAX | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| April 15, 2021 | K210539 | CoreLink Midline Fixation System | NKB | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| December 28, 2020 | K201781 | Uni-FuZe-P Bone Putty | MQV | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| December 23, 2020 | K202637 | F3D Corpectomy System | MQP | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| November 4, 2020 | K202624 | Z-Span Plate System | KWQ | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| October 19, 2020 | K200084 | Zavation IBF System | MAX | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| October 13, 2020 | K202305 | Zavation IBF System | MAX | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| June 15, 2020 | K200087 | F3D Cervical Stand-Alone Interbody Fusion System | OVE | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| April 28, 2020 | K200863 | Tiger® Occipital-Cervical-Thoracic Spinal Fixation System | NKG | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| December 13, 2019 | K182731 | Corelink Navigation Instruments | OLO | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| September 9, 2019 | K191354 | Ti3Z Cervical Interbody System | ODP | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| August 19, 2019 | K191339 | Zavation eZspand Interbody System | MAX | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| August 6, 2019 | K191423 | Normandy VBR System | PLR | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| June 12, 2019 | K190016 | Lateral Plate System | KWQ | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| April 11, 2019 | K190317 | Zavation Spinal System | NKB | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| March 18, 2019 | K190361 | Zavation Spinal System | NKB | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| December 19, 2018 | K183239 | CoreLink F3D Lateral System | MAX | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| August 10, 2018 | K180814 | CoreLink® M3 Stand-Alone Anterior Lumbar System | OVD | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| July 27, 2018 | K180556 | Corelink Foundation 3D Anterior Lumbar System | MAX | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| July 27, 2018 | K180076 | Ti 3Z Interbody System | MAX | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| July 13, 2018 | K180673 | Normandy VBR System | PLR | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| July 10, 2018 | K181246 | Zavation IBF System | MAX | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| July 10, 2018 | K181244 | Zavation Cervical Plate System | KWQ | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| March 16, 2018 | K173752 | SI Screw System | OUR | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| January 22, 2018 | K173306 | EZ Plate | KWQ | Substantially Equivalent | Zavation Medical Products, LLC | accessdata.fda.gov |
| September 15, 2017 | K171519 | FLXfit | MAX | Substantially Equivalent | Expanding Orthopedics, Inc. | accessdata.fda.gov |
| June 21, 2017 | K163104 | Terrace Anterior Cervical Plate System | KWQ | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| May 4, 2017 | K162496 | Foundation 3D Interbody | ODP | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| April 4, 2017 | K162206 | Zavation IBF | MAX | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| March 3, 2017 | K162575 | Z-LINKPC System | NKG | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| February 17, 2017 | K162824 | Z-Span Plate System | KWQ | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| November 1, 2016 | K162453 | 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) | NDN | Substantially Equivalent | Pan Medical , Ltd. | accessdata.fda.gov |
| October 19, 2016 | K161016 | Z-Clamp ISP System | PEK | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| April 21, 2016 | K153404 | Zavation Spinal System | MNH | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| March 22, 2016 | K160362 | Z-Span Plate System | KWQ | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| February 4, 2016 | K152237 | The Entasis Dual-Lead Sacroiliac Implant | OUR | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| August 13, 2015 | K150847 | Foundation Interbody Devices | ODP | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| April 29, 2015 | K142392 | Zavation Posterior LEIF | MAX | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| March 6, 2015 | K150322 | InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) | NDN | Substantially Equivalent | Pan Medical , Ltd. | accessdata.fda.gov |
| February 26, 2015 | K143228 | Ancora LLC Interbody Fusion Device | OVD | Substantially Equivalent | Frontier Medical Devices, Inc. | accessdata.fda.gov |
| December 19, 2014 | K142271 | Zavation Z-Link Lumbar | OVD | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| September 12, 2014 | K141419 | ZVPLASTY | NDN | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| August 7, 2014 | K141005 | Z-LINK CERVICAL | OVE | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| July 16, 2014 | K140844 | BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC | MQV | Substantially Equivalent | Synergy Biomedical, Inc. | accessdata.fda.gov |
| July 15, 2014 | K133813 | FLXFIT INTERVERTEBRAL BODY FUSION DEVICE | MAX | Substantially Equivalent | Expanding Orthopedics, Inc. | accessdata.fda.gov |
| April 16, 2014 | K132620 | INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL | NDN | Substantially Equivalent | Pan Medical , Ltd. | accessdata.fda.gov |
| January 14, 2014 | K133369 | TIGER SPINE SYSTEM | NKB | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| December 5, 2013 | K132994 | ANODYNE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| November 25, 2013 | K132504 | TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| October 28, 2013 | K132126 | SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM | MRW | Substantially Equivalent | Spectrum Spine, LLC | accessdata.fda.gov |
| September 10, 2013 | K131250 | TIGER SPINE SYSTEM | NKB | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| April 25, 2013 | K130030 | ZAVATION CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| December 14, 2012 | K121514 | ANODYNE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| November 19, 2012 | K121791 | ZOU ANTERIOR LUMBAR PLATE SYSTEM | KWQ | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| November 1, 2012 | K112700 | FRONTIER SADL INTERBODY FUSION DEVICE | OVD | Substantially Equivalent | Frontier Medical Devices, Inc. | accessdata.fda.gov |
| October 5, 2012 | K121728 | TIGER SPINE SYSTEM | NKB | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| April 2, 2012 | K120696 | TIGER SPINE SYSTEM | MNI | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| March 29, 2012 | K113058 | TIGER SPINE SYSTEM | NKB | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| March 28, 2012 | K120576 | ZAVATION IBF SYSTEM | MAX | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| December 23, 2011 | K112664 | ZAVATION IBF SYSTEMS | ODP | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| December 8, 2011 | K112533 | ZAVATION CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| November 22, 2011 | K112484 | ZAVATION SPINAL SYSTEM | MNI | Substantially Equivalent | Zavation, LLC | accessdata.fda.gov |
| May 25, 2011 | K110321 | TIGER SPINE SYSTEM | MNH | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| December 27, 2010 | K102937 | OSTEOPHIL BETA-TCP | MQV | Substantially Equivalent | Cytophil, Inc. | accessdata.fda.gov |
| April 24, 2008 | K073440 | FOUNDATION CAGE | MAX | Substantially Equivalent | Corelink, LLC | accessdata.fda.gov |
| January 25, 2006 | K052812 | OSSIMEND (TM) BONE GRAFT MATERIAL | MQV | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 25, 2021 | 87661 | Class II | Terminated | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Spinal Vertebral Body Replacement Device
- All makers of Spinal Vertebral Body Replacement Device - Cervical
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Cutter, Wire
Updated February 3, 2025. 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.