Company ยท US
Zavation Medical Products, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 9 |
| NKB | Thoracolumbosacral Pedicle Screw System | 7 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 |
| MQV | Filler, Bone Void, Calcium Compound | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 2 |
| NKG | Posterior Cervical Screw System | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 |
| OUR | Sacroiliac Joint Fixation | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2026 | K253943 | Tiger 2 System Zavation Medical Products, LLC | NKB |
| Feb 3, 2025 | K243908 | Tiger 2 System Zavation Medical Products, LLC | NKB |
| Apr 10, 2024 | K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System Zavation Medical Products, LLC | MAX |
| Aug 22, 2023 | K231811 | Zavation Connector System Zavation Medical Products, LLC | NKB |
| Jul 12, 2023 | K223808 | Zavation Navigation Instrument System Zavation Medical Products, LLC | OLO |
| Jun 14, 2023 | K230731 | Zavation ALIF System Zavation Medical Products, LLC | OVD |
| Jan 18, 2023 | K221726 | Uni-FuZe-C Bone Strip Zavation Medical Products, LLC | MQV |
| Dec 5, 2022 | K222614 | Zavation Spinal System Zavation Medical Products, LLC | NKB |
| Aug 12, 2022 | K221049 | Zavation VariSync Plate System and VariSync Spacer System Zavation Medical Products, LLC | OVE |
| Jun 2, 2022 | K220581 | Zavation eZspand Interbody System Zavation Medical Products, LLC | MAX |
| Apr 12, 2022 | K212811 | Ti3Z Lumbar Interbody System Zavation Medical Products, LLC | MAX |
| Aug 11, 2021 | K211993 | Z-LINKPC System Zavation Medical Products, LLC | NKG |
| Jul 12, 2021 | K211113 | Zavation Spinal System Zavation Medical Products, LLC | NKB |
| Jun 24, 2021 | K211306 | LABYRINTH Zavation Medical Products, LLC | MAX |
| Jan 29, 2021 | K202398 | Ti3Z Cervical Interbody System Zavation Medical Products, LLC | ODP |
| Dec 28, 2020 | K201781 | Uni-FuZe-P Bone Putty Zavation Medical Products, LLC | MQV |
| Nov 4, 2020 | K202624 | Z-Span Plate System Zavation Medical Products, LLC | KWQ |
| Oct 19, 2020 | K200084 | Zavation IBF System Zavation Medical Products, LLC | MAX |
| Oct 13, 2020 | K202305 | Zavation IBF System Zavation Medical Products, LLC | MAX |
| Sep 9, 2019 | K191354 | Ti3Z Cervical Interbody System Zavation Medical Products, LLC | ODP |
| Aug 19, 2019 | K191339 | Zavation eZspand Interbody System Zavation Medical Products, LLC | MAX |
| Aug 6, 2019 | K191423 | Normandy VBR System Zavation Medical Products, LLC | PLR |
| Apr 11, 2019 | K190317 | Zavation Spinal System Zavation Medical Products, LLC | NKB |
| Mar 18, 2019 | K190361 | Zavation Spinal System Zavation Medical Products, LLC | NKB |
| Jul 27, 2018 | K180076 | Ti 3Z Interbody System Zavation Medical Products, LLC | MAX |
| Jul 13, 2018 | K180673 | Normandy VBR System Zavation Medical Products, LLC | PLR |
| Jul 10, 2018 | K181246 | Zavation IBF System Zavation Medical Products, LLC | MAX |
| Jul 10, 2018 | K181244 | Zavation Cervical Plate System Zavation Medical Products, LLC | KWQ |
| Mar 27, 2018 | K180537 | Zavation Buttress Plate System Zavation Medical Products, LLC | KWQ |
| Mar 16, 2018 | K173752 | SI Screw System Zavation Medical Products, LLC | OUR |
| Jan 22, 2018 | K173306 | EZ Plate Zavation Medical Products, LLC | KWQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||