GRAMERCY EXTREMITY ORTHOPEDICS, LLC.

FDA Device Registration & Listing · Richardson, TX, US · Registration 3012478585

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
3012478585
FEI Number
3012478585
Entity Name
GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
City/State/Country
Richardson, TX, US
Establishment Address
1239 N Glenville Dr, Richardson, TX 75081, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Gramercy Extremity Orthopedics, LLC. (Owner Number: 10053967)
Owner / Operator Contact Address
1239 N. Glenville Drive, Richardson, TX 75081, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K170571
PMA Number
N/A

All Registered Proprietary Names

Sagittal Saw Blade GEO 1st MTP Joint Arthrodesis Plating System GEO 1st MTP Joint Arthrodesis Plating System GEO Bone Screw System GEO Extremity and Ankle Plating System GEO Hammertoe Screw

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2025-01-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-02-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-02-02
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2017-01-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-01-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-04-27

Official Correspondent

John Rigol

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gramercy Extremity Orthopedics, LLC.
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
K953012 Boston Surgical Products, Inc. DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS 1995-07-12
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
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.

Similar Registrations

Registration Number Establishment Name Location
1318997 PUTNAM PRECISION PRODUCTS, INC. BREWSTER, NY, US
3010591625 GOMINA AG Niederwald Valais, CH
3005575604 SURETEK MEDICAL GREENVILLE, SC, US
8043971 T.A.G. MEDICAL PRODUCTS CORPORATION LTD GAATON Northern, IL
3027344440 TRITEX MEDICAL MANUFACTURING LLC Mount Morris, MI, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012478585. Last updated year: 2026. Please use registration number 3012478585 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.