# Zsfab, Inc.

- Location (FDA's records): Waltham, MA
- FDA decisions: 8 (2021–2026): 8 510(k) clearances
- Names in FDA's records: Zsfab, Inc. (5); ZSFab, Inc. (2); Zsfab (1)
- Product codes: ODP (4), MAX (2), OVE (2)
- 510(k) review time since 2016: median 78 days, against 90 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 19 (10 its own); citations of its devices by later devices: 10 (10 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
- K2m, Inc.: 4 (https://510kreport.com/company/k2m)
- Choicespine, LP: 1 (https://510kreport.com/company/choicespine)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Happe Spine: 1 (https://510kreport.com/company/happe-spine)
- SeaSpine Orthopedics Corporation: 1 (https://510kreport.com/company/seaspine-orthopedics)
- Kyocera Medical Technologies Inc. (KMTI): 1 (https://510kreport.com/company/kyocera-medical-technologies-kmti)

## Its most-cited devices
- K202488: ZSFab Cervical Interbody System (2021), cited by 3
- K242734: ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System (2024), cited by 3
- K221858: ZSFab Lumbar Interbody System (2022), cited by 2
- K252610: ZSFab Lumbar Interbody System (2025), cited by 1
- K232150: ZSFab Cervical Interbody System (2023), cited by 1

## Recent decisions
- K263113: ZSAlign Cervical Interbody System (Oct 2, 2026)
- K261451: ZSAlign Cervical Interbody System (Jul 31, 2026)
- K260549: ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (Apr 24, 2026)
- K252610: ZSFab Lumbar Interbody System (Nov 25, 2025)
- K242734: ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System (Nov 7, 2024)
- K232150: ZSFab Cervical Interbody System (Aug 18, 2023)
- K221858: ZSFab Lumbar Interbody System (Oct 14, 2022)
- K202488: ZSFab Cervical Interbody System (Jan 7, 2021)

Source page: https://510kreport.com/company/zsfab