FDA Registration
Active
🇺🇸 United States
A.M. SURGICAL, INC.
Reg #: 2437731
·
FEI: 3001617730
·
Expires 2026
Products
13
Proprietary Names
41
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- A.M. SURGICAL, INC.
- Registration Number
- 2437731
- FEI Number
- 3001617730
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 402 Amherst St Ste 300
- City
- Nashua
- State
- NH
- ZIP
- 03063
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191771
Owner / Operator
- Firm Name
- A.M. SURGICAL, INC.
- Operator Number
- 9032254
- Address
- 402 Amherst Street Ste 300, --
- City
- Nashua
- State
- NH
- Postal Code
- 03063
- Country
- US
- Correspondent
- Vincent F Pascale
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2026-06-11 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-09-21 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2009-02-20 |
| Table, Operating-Room, Manual | FSE | Class 1 | General, Plastic Surgery | No | 2009-06-04 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2026-06-04 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2008-10-20 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2018-05-29 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2009-06-01 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 1997-11-21 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2010-10-21 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2026-06-04 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2009-05-07 |
| Table, Surgical With Orthopedic Accessories, Manual | JEB | Class 1 | General, Plastic Surgery | No | 2026-06-04 |
Proprietary Names
Velcro Strap
Secure Screw
Metal Cannula
Clear Plastic Cannula
Hand Table
IM Nail AWL
Cross Pin Fixation System
CPX Tightening Tool
Tissue Protector
Secure IM Nail
Dilator-Small
Dilator-Medium
Dilator-Large
Obutrator for ECTR/ECuTR
Locking Attachment
Endoscopic Blade
STRATOS Endoscopic Carpal Tunnel Release System
Endoscopic Trigger Shield Release
Endoscopic Trigger Finger Release (ETFR)
Ultra Endoscopic Soft Tissue Release System
EndoSleeve
LITE Endoscopic Gastrocnemius Release System
STRATOS Endoscopic Gastrocnemius Release System
Endoscopic Cubital Tunnel Release (ECUTR)
Ultra Endoscopic Plantar Fascia Release System
STRATOS Endoscopic Plantar Fascia Release System
LITE Endoscopic Plantar Fascia Release System
Ultra Endoscopic Gastrocnemius Release System
LITE Endoscopic Release System
RETRA Endoscopic Cubital Tunnel Release System
LITE Endoscopic Mortons Neuroma Decompression System
RETRA Endoscopic Carpal Tunnel Release System
LITE Endoscopic Tarsal Tunnel Release System
STRATOS RETRA Endoscopic Gastrocnemius Release System
STRATOS RETRA Endoscopic Plantar Fascia Release System
STRATOS RETRA Endoscopic Carpal Tunnel Release System
Scope Adapter
Endo Tray
Elevator for ECTR/ECuTR
Elevator
Table Pad
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility