# Zavation Medical Products, LLC

- Location (FDA's records): Flowood, MS
- FDA decisions: 31 (2018–2026): 31 510(k) clearances
- Product codes: MAX (9), NKB (7), KWQ (4), ODP (2), PLR (2), MQV (2), OLO (1), OVE (1), OUR (1), NKG (1), OVD (1)
- 510(k) review time since 2016: median 93 days, against 92 for FDA's reviews in the same codes and years (15 of 31 faster)
- Predicates its devices cite: 87 (30 its own); citations of its devices by later devices: 38 (30 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Zavation, LLC: 13 (https://510kreport.com/company/zavation)
- Globus Medical, Inc.: 7 (https://510kreport.com/company/globus-medical)
- Orthofix, Inc.: 5 (https://510kreport.com/company/orthofix)
- Medtronic Sofamor Danek: 3 (https://510kreport.com/company/medtronic-sofamor-danek)
- X-Spine Systems, Inc.: 2 (https://510kreport.com/company/x-spine-systems)
- Ulrich GmbH & Co. KG: 2 (https://510kreport.com/company/ulrich)
- Medtronic Vascular: 2 (https://510kreport.com/company/medtronic-vascular)
- Omni Surgical, L.P.: 1 (https://510kreport.com/company/omni-surgical)

## Firms that cite its devices most
- Republic Spine, LLC: 1 (https://510kreport.com/company/republic-spine)
- K2m, Inc.: 1 (https://510kreport.com/company/k2m)
- Kyocera Medical Technologies Inc. (KMTI): 1 (https://510kreport.com/company/kyocera-medical-technologies-kmti)
- Stryker Spine: 1 (https://510kreport.com/company/stryker-spine)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Expanding Innovations, Inc.: 1 (https://510kreport.com/company/expanding-innovations)
- Precision Spine, Inc.: 1 (https://510kreport.com/company/precision-spine)
- Intelivation Technologies: 1 (https://510kreport.com/company/intelivation-technologies)

## Its most-cited devices
- K181246: Zavation IBF System (2018), cited by 7
- K200084: Zavation IBF System (2020), cited by 3
- K191354: Ti3Z Cervical Interbody System (2019), cited by 3
- K221049: Zavation VariSync Plate System and VariSync Spacer System (2022), cited by 2
- K211306: Labyrinth (2021), cited by 2
- K222614: Zavation Spinal System (2022), cited by 2

## Recent decisions
- K253943: Tiger 2 System (Jul 24, 2026)
- K243908: Tiger 2 System (Feb 3, 2025)
- K233509: Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System (Apr 10, 2024)
- K231811: Zavation Connector System (Aug 22, 2023)
- K223808: Zavation Navigation Instrument System (Jul 12, 2023)
- K230731: Zavation ALIF System (Jun 14, 2023)
- K221726: Uni-FuZe-C Bone Strip (Jan 18, 2023)
- K222614: Zavation Spinal System (Dec 5, 2022)

Source page: https://510kreport.com/company/zavation-medical-products