Data / Medical devices / United States / A.M. Surgical, Inc.
A.M. Surgical, Inc.: FDA-registered device maker in Nashua, NH, United States, 3 510(k) clearances
A.M. Surgical, Inc. is registered with the FDA (registration 2437731) in Nashua, NH, United States. It lists 13 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 16, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2437731
- FEI number
- 3001617730
- Address
- 402 Amherst St Ste 300, Nashua, NH, United States, 03063
- Owner or operator
- A.M. SURGICAL, INC. (9032254)
- Roles
- Specification developer
- First device listed
- November 21, 1997
- Registered through
- 2027
- Brand names listed
- CPX Tightening Tool, Clear Plastic Cannula, Cross Pin Fixation System, Dilator-Large, Dilator-Medium, Dilator-Small, Elevator, Elevator for ECTR/ECuTR and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 16, 2019 | K191771 | SECURE Screw | HWC | Substantially Equivalent | A.M. Surgical, Inc. | accessdata.fda.gov |
| May 18, 2018 | K180087 | A.M. Surgical Intramedullary Fixation Device | HTY | Substantially Equivalent | A.M. Surgical, Inc. | accessdata.fda.gov |
| October 7, 2004 | K042458 | A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM | LXT | Substantially Equivalent | A.M. Surgical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Pin, Fixation, Smooth
- All makers of Screw, Fixation, Bone
- All makers of Support, Arm
- All makers of Tray, Surgical, Instrument
- All makers of Awl
- All makers of Table, Operating-Room, Manual
Updated October 16, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.