Zavation Medical Products, LLC
Flowood, MS, US
Zavation Medical Products, LLC appears in FDA device records in Flowood, MS. FDA records list 31 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 31
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 31 510(k) clearances for Zavation Medical Products, LLC between 2018 and 2026. The busiest year on record is 2018, with 7. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 7 |
| 2019 | 5 |
| 2020 | 4 |
| 2021 | 4 |
| 2022 | 4 |
| 2023 | 4 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253943 | Tiger 2 System | NKB | Substantially Equivalent | |
| K243908 | Tiger 2 System | NKB | Substantially Equivalent | |
| K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System | MAX | Substantially Equivalent | |
| K231811 | Zavation Connector System | NKB | Substantially Equivalent | |
| K223808 | Zavation Navigation Instrument System | OLO | Substantially Equivalent | |
| K230731 | Zavation ALIF System | OVD | Substantially Equivalent | |
| K221726 | Uni-FuZe-C Bone Strip | MQV | Substantially Equivalent | |
| K222614 | Zavation Spinal System | NKB | Substantially Equivalent | |
| K221049 | Zavation VariSync Plate System and VariSync Spacer System | OVE | Substantially Equivalent | |
| K220581 | Zavation eZspand Interbody System | MAX | Substantially Equivalent | |
| K212811 | Ti3Z Lumbar Interbody System | MAX | Substantially Equivalent | |
| K211993 | Z-LINKPC System | NKG | Substantially Equivalent | |
| K211113 | Zavation Spinal System | NKB | Substantially Equivalent | |
| K211306 | LABYRINTH | MAX | Substantially Equivalent | |
| K202398 | Ti3Z Cervical Interbody System | ODP | Substantially Equivalent | |
| K201781 | Uni-FuZe-P Bone Putty | MQV | Substantially Equivalent | |
| K202624 | Z-Span Plate System | KWQ | Substantially Equivalent | |
| K200084 | Zavation IBF System | MAX | Substantially Equivalent | |
| K202305 | Zavation IBF System | MAX | Substantially Equivalent | |
| K191354 | Ti3Z Cervical Interbody System | ODP | Substantially Equivalent | |
| K191339 | Zavation eZspand Interbody System | MAX | Substantially Equivalent | |
| K191423 | Normandy VBR System | PLR | Substantially Equivalent | |
| K190317 | Zavation Spinal System | NKB | Substantially Equivalent | |
| K190361 | Zavation Spinal System | NKB | Substantially Equivalent | |
| K180076 | Ti 3Z Interbody System | MAX | Substantially Equivalent | |
| K180673 | Normandy VBR System | PLR | Substantially Equivalent | |
| K181246 | Zavation IBF System | MAX | Substantially Equivalent | |
| K181244 | Zavation Cervical Plate System | KWQ | Substantially Equivalent | |
| K180537 | Zavation Buttress Plate System | KWQ | Substantially Equivalent | |
| K173752 | SI Screw System | OUR | Substantially Equivalent | |
| K173306 | EZ Plate | KWQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWQAppliance, Fixation, Spinal Intervertebral Body
- MQVFiller, Bone Void, Calcium Compound
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- OLOOrthopedic Stereotaxic Instrument
- NKGPosterior Cervical Screw System
- OURSacroiliac Joint Fixation
- PLRSpinal Vertebral Body Replacement Device - Cervical
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain