A.M. SURGICAL, INC.

FDA Device Registration & Listing · Nashua, NH, US · Registration 2437731

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2437731
FEI Number
3001617730
Entity Name
A.M. SURGICAL, INC.
City/State/Country
Nashua, NH, US
Establishment Address
402 Amherst St Ste 300, Nashua, NH 03063, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
A.M. SURGICAL, INC. (Owner Number: 9032254)
Owner / Operator Contact Address
402 Amherst Street Ste 300, --, Nashua, NH 03063, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IOY Support, Arm Physical Medicine Class 1 890.3475 2026-06-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-09-21
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2009-02-20
FSE Table, Operating-Room, Manual General, Plastic Surgery Class 1 878.4950 2009-06-04
HWJ Awl Orthopedic Class 1 888.4540 2026-06-04
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2008-10-20
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2018-05-29
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2009-06-01
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 1997-11-21
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2010-10-21
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2026-06-04

Official Correspondent

Vincent Pascale

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

A.M. SURGICAL, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2437731. Last updated year: 2026. Please use registration number 2437731 when referencing this establishment in official correspondence.
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