# Tyber Medical, LLC

- Location (FDA's records): Bethlehem, PA
- FDA decisions: 31 (2013–2026): 31 510(k) clearances
- Product codes: HRS (11), HWC (9), ODP (4), OLO (2), PLF (2), JDR (1), HTY (1), OVD (1)
- 510(k) review time since 2016: median 90 days, against 110 for FDA's reviews in the same codes and years (14 of 26 faster)
- Predicates its devices cite: 84 (40 its own); citations of its devices by later devices: 57 (40 its own)
- Recalls linked to its devices: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biopro, Inc.: 4 (https://510kreport.com/company/biopro)
- Wrightmedicaltechnologyinc: 4 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Medtronic Sofamor Danek USA, Inc.: 4 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Depuy Spine, Inc.: 3 (https://510kreport.com/company/depuy-spine)
- Aesculap Implant Systems, LLC: 3 (https://510kreport.com/company/aesculap-implant-systems)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Biomedical Enterprises, Inc.: 2 (https://510kreport.com/company/biomedical-enterprises)
- Medartis AG: 2 (https://510kreport.com/company/medartis)

## Firms that cite its devices most
- MedShape, Inc.: 2 (https://510kreport.com/company/medshape)
- Cutting Edge Spine, LLC: 1 (https://510kreport.com/company/cutting-edge-spine)
- Skeletal Dynamics, Inc.: 1 (https://510kreport.com/company/skeletal-dynamics)
- Corelink, LLC: 1 (https://510kreport.com/company/corelink)
- Nvision Biomedical Technologies, Inc.: 1 (https://510kreport.com/company/nvision-biomedical-technologies)
- Integrity Implants, Inc.: 1 (https://510kreport.com/company/integrity-implants)
- Kuros Biosciences B.V: 1 (https://510kreport.com/company/kuros-biosciences-b-v)
- Met One Technologies, LLC: 1 (https://510kreport.com/company/met-one-technologies)

## Its most-cited devices
- K130573: Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif (2013), cited by 11
- K133842: Tyber Medical Trauma Screw (2014), cited by 8
- K222465: Tyber Medical Anatomical Plating System (2023), cited by 6
- K193222: Tyber Medical Anatomical Plating System (2020), cited by 4
- K153575: Tyber Medical Trauma Screw (2016), cited by 4
- K203817: Tyber Medical Anatomical Plating System (2021), cited by 4

## Recent decisions
- K261207: Exalta Proximal Tibia Plating System (Jun 12, 2026)
- K260810: Anteralign LS coverplate (Jun 10, 2026)
- K261060: Navigated LLIF Impactable Tracker (May 29, 2026)
- K253042: Tyber Medical Trauma Screw (Apr 3, 2026)
- K252901: Tyber Medical Trauma Screw (Dec 31, 2025)
- K252742: Navigated Instruments (Oct 28, 2025)
- K251361: Tyber Medical Distal Radius Plating System (Jul 30, 2025)
- K242486: Tyber Medical Anatomical Plating System (Mar 19, 2025)

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