SECURE Screw
A.M. Surgical, Inc.
A.M. SURGICAL, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2437731 | 3001617730 | A.M. SURGICAL, INC. | 1 | Y | 2026-01-01 | 402 Amherst St Ste 300 Nashua NH US 03063 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 54192 | 1989746653 | K191771 | SECURE Screw | HWC | 2019-10-16 |
| 54192 | 1014462096 | K191345 | Pegasus System | HRX | 2019-07-17 |
| 54192 | 1989870792 | K180087 | A.M. Surgical Intramedullary Fixation Device | HTY | 2018-05-18 |
| 54192 | 1017754825 | K042458 | A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM | LXT | 2004-10-07 |
| 54192 | 1151430229 | ||||
| 54192 | 1198034652 | ||||
| 54192 | 1286564175 | ||||
| 54192 | 1607524910 | ||||
| 54192 | 1612502197 | ||||
| 54192 | 1695642437 | ||||
| 54192 | 1723027142 | ||||
| 54192 | 2005255993 | ||||
| 54192 | 2013534600 | ||||
| 54192 | 2034268486 |
Product Codes Associated With Registrations#
PMN#
Pegasus System
A.M. Surgical, Inc.
MOUNTABLE ENDOSCOPIC BLADE
A.M. SURGICAL, INC.
A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
A.M. SURGICAL, INC.
MOUNTABLE ENDOSCOPIC KNIFE
A.M. SURGICAL, INC.
GUDID#
IM Nail Awl - 8900-20
2026-06-10
Measuring Device - 8900-51
2026-06-10
STRATOS Endoscopic Release System (GEN 2) Case of 5 - 5500-B
2026-06-10
Table Pad - 9501
2026-06-10
Table Pads (5-pack) - 9501-B
2026-06-10
STRATOS Endo Release Kit (GEN 2) Case of 5 - 5500-K
2026-06-10
STRATOS (Gen2) - 5500-2
2026-06-05
RetraBE Single - Gen 2 Depricated - 5500-SRB
2026-06-04
Hand Table - 9500
2026-06-04
Endo ECTR Tray - 9600
2026-06-04
Retra Uni Gen 1 (5-Pack) - 5500-UB
2026-06-04
Retra Uni Gen 1 Single - 5500-U
2026-06-04
RETRA Single - GEN 2 Depricated - 5500-RB
2026-06-04
Scope Adapter - 1200-01
2026-06-01
Obturator - 9600-01
2026-06-01
Cannula - 9600-02
2026-06-01
Rasp - 9600-03
2026-06-01
Locking Attachment - 9600-04
2026-05-20
Stratos - Endoscopic Release System (GEN1)
2019-07-17
RETRA - RETRA Endoscopic Release System (G2) STERILE For Single Use Only
2026-05-20
RETRA - RETRA Endoscopic Release System (G2) STERILE For Single Use Only
2026-05-20
Elevator - 9600-06
2026-05-20
Dilator-Small - 9600-07
2026-05-20
Dilator-Medium - 9600-08
2026-05-20
Dilator-Large - 9600-09
2026-05-20
Secure IM Nail - One 65mm x 1.6mm IM Nail
2019-11-14
Secure IM Nail - One 70mm x 1.6mm IM Nail
2019-11-14
Secure IM Nail - One 30mm x 1.2mm IM Nail
2019-11-14
Secure IM Nail - One 35mm x 1.2mm IM Nail
2019-11-14
Secure IM Nail - One 40mm x 1.2mm IM Nail
2019-11-14
Secure IM Nail - One 45mm x 1.2mm IM Nail
2019-11-14
Secure IM Nail - One 50mm x 1.2mm IM Nail
2019-11-14
Secure IM Nail - One 55mm x 1.2mm IM Nail
2019-11-14
Secure IM Nail - One 60mm x 1.2mm IM Nail
2019-11-14
Secure IM Nail - One 65mm x 1.2mm IM Nail
2019-11-14
Secure IM Nail - One 70mm x 1.2mm IM Nail
2019-11-14
Secure IM Nail - One 40mm x 1.6mm IM Nail
2018-07-16
Secure IM Nail - One 45mm x 1.6mm IM Nail
2018-07-16
Secure IM Nail - One 50mm x 1.6mm IM Nail
2018-07-16
Secure IM Nail - One 55mm x 1.6mm IM Nail
2018-07-16