# Wenzel Spine, Inc.

- Location (FDA's records): Austin, TX
- FDA decisions: 10 (2010–2026): 10 510(k) clearances
- Names in FDA's records: Wenzel Spine, Inc. (7); Wenzel Spine (3)
- Product codes: MAX (4), ODP (4), PEK (1), OUR (1)
- 510(k) review time since 2016: median 163 days, against 117 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 28 (7 its own); citations of its devices by later devices: 14 (7 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
- Depuy Spine, Inc.: 4 (https://510kreport.com/company/depuy-spine)
- Medtronic Sofamor Danek: 3 (https://510kreport.com/company/medtronic-sofamor-danek)
- Zimmer Spine, Inc.: 2 (https://510kreport.com/company/zimmer-spine)
- Stryker Spine: 2 (https://510kreport.com/company/stryker-spine)
- Sulzer Spine-Tech: 2 (https://510kreport.com/company/sulzer-spine-tech)
- Ldr Spine USA: 1 (https://510kreport.com/company/ldr-spine-usa)
- Amendia, Inc.: 1 (https://510kreport.com/company/amendia)
- Medical Designs, LLC: 1 (https://510kreport.com/company/medical-designs)

## Firms that cite its devices most
- Alphatec Spine, Inc.: 2 (https://510kreport.com/company/alphatec-spine)
- Providence Medical Technology, Inc.: 1 (https://510kreport.com/company/providence-medical-technology)
- Orthofix Medical, Inc.: 1 (https://510kreport.com/company/orthofix-medical)
- K2m, Inc.: 1 (https://510kreport.com/company/k2m)
- Medyssey USA, Inc.: 1 (https://510kreport.com/company/medyssey-usa)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)

## Its most-cited devices
- K120603: Varilift -C (2013), cited by 4
- K100820: Wenzel Spine Varilift Interbody Fusion System (2010), cited by 3
- K151900: VariLift-L Interbody Fusion Device (2015), cited by 2
- K111123: Varilift Cervical Interbody Fusion System (2011), cited by 2
- K231076: VariLift®-C Interbody Fusion System (2023), cited by 2
- K180822: VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System (2019), cited by 1

## Recent decisions
- K262595: VariLift-C Cervical Interbody Fusion System (Aug 26, 2026)
- K250247: panaSIa SI Fusion System (Jul 9, 2025)
- K231076: VariLift®-C Interbody Fusion System (Sep 27, 2023)
- K231807: primaLOK™ SP Interspinous Fusion System (Aug 15, 2023)
- K180822: VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System (Jan 28, 2019)
- K151900: VariLift-L Interbody Fusion Device (Dec 11, 2015)
- K131296: Varilift-L Interbody Fusion Device (Sep 3, 2013)
- K120603: Varilift -C (Jan 29, 2013)

Source page: https://510kreport.com/company/wenzel-spine