# Precifit Medical, Ltd.

- Location (FDA's records): Morrisville, NC
- FDA decisions: 4 (2017–2018): 4 510(k) clearances
- Product codes: MAX (2), HTY (1), ODP (1)
- 510(k) review time since 2016: median 205 days, against 122 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 7 (2 its own); citations of its devices by later devices: 2 (2 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
- Medtronic Sofamor Danek USA, Inc.: 3 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- In2bones Sas: 1 (https://510kreport.com/company/in2bones)
- Medtronic Sofamor Danck USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danck-usa)

## Its most-cited devices
- K171630: LumFuse-TP (2017), cited by 1
- K172568: Cervage (2018), cited by 1

## Recent decisions
- K173189: Lumfuse TP (Jun 8, 2018)
- K172568: Cervage (May 4, 2018)
- K171630: LumFuse-TP (Jul 25, 2017)
- K163327: Precifit Medical Kirschner Wires (May 8, 2017)

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