Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004993707

FEI Number

3004993707

Entity Name

Graham Medical Technologies, L.L.C. d.b.a. GraMedica

City/State/Country

Rochester, MI, US

Establishment Address

236 Mill St, Rochester, MI 48307, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

GRAMEDICA (Owner Number: 9069880)

Owner / Operator Contact Address

236 Mill Street, --, Rochester, MI 48307, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

osteo-WEDGE Drill Guide HyProCure Sizer 06 HyProCure II Trial Sizer 10 HyProCure Sizer 05 osteo-WEDGE Depth Gauge osteo-WEDGE Screw Retainer Sleeve Guide Wire HyProCure II Positioning Sleeve HyProCure Sizer 07 HyProCure Driver HyProCure II Trial Sizer 09 osteo-WEDGE Depth Gauge Sleeve HyProCure II Trial Sizer 08 HyProCure II Trial Sizer 07 HyProCure II Driver HyProCure Sizer 09 osteo-WEDGE Driver HyProCure II Trial Sizer 12 HyProCure II Trial Sizer 06 HyProCure Sizer 08 HyProCure Sizer 10 Opti-Toe osteo-WEDGE Opening Wedge Bone Locking Plate System HYP Sinus Tarsi Decompression Scissors Graham Decompression Scissors

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-02-21
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2016-01-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-12-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-12-15
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2016-02-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GRAMEDICA

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
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23
K850026	Kirkstil Corp., Inc.	ORTHOPEDIC IMPLANT NAILS & PINS	1985-05-20
K963367	Rms Div.	RMS K-WIRE	1996-10-30
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004993707. Last updated year: 2026. Please use registration number 3004993707 when referencing this establishment in official correspondence.