# A.M. Surgical, Inc.

- Location (FDA's records): Smithtown, NY
- FDA decisions: 6 (1998–2019): 6 510(k) clearances
- Product codes: EMF (2), HWC (1), LXT (1), HRX (1), HTY (1)
- 510(k) review time since 2016: median 106 days, against 108 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 6 (1 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
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Biomet Orthopedics, Inc.: 1 (https://510kreport.com/company/biomet-orthopedics)
- Trice Medical, Inc.: 1 (https://510kreport.com/company/trice-medical)

## Firms that cite its devices most
- Microaire Surgical Instruments, LLC: 2 (https://510kreport.com/company/microaire-surgical-instruments)
- Pavmed, Inc.: 1 (https://510kreport.com/company/pavmed)
- Mondeal North America, Inc.: 1 (https://510kreport.com/company/mondeal-north-america)
- Socorro Medical, Inc.: 1 (https://510kreport.com/company/socorro-medical)

## Its most-cited devices
- K080133: Mountable Endoscopic Blade (2008), cited by 4
- K982142: Mountable Endoscopic Knife (1998), cited by 2

## Recent decisions
- K191771: SECURE Screw (Oct 16, 2019)
- K191345: Pegasus System (Jul 17, 2019)
- K180087: A.M. Surgical Intramedullary Fixation Device (May 18, 2018)
- K080133: Mountable Endoscopic Blade (Mar 13, 2008)
- K042458: A.M. Surgical CPF Distal Radial External Cross Pin Fixation System (Oct 7, 2004)
- K982142: Mountable Endoscopic Knife (Dec 30, 1998)

Source page: https://510kreport.com/company/am-surgical