Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1226191

FEI Number

3002758924

Entity Name

Tegra Medical - Franklin, MA

City/State/Country

Franklin, MA, US

Establishment Address

16 Forge Parkway, Franklin, MA 02038, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tegra Medical, LLC (Owner Number: 10042471)

Owner / Operator Contact Address

16 Forge Parkway, Franklin, MA 02038, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nitinol Guidewire, 9"x42"

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2013-01-15
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-22
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-22
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2016-04-04
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-06-08
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-01-22

Official Correspondent

Daniel Snell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tegra Medical, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1219114	Tegra Medical - Dartmouth, MA	DARTMOUTH, MA, US

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

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.

Similar Registrations

Registration Number	Establishment Name	Location
3013011598	MAHE MEDICAL USA	Laramie, WY, US
3007728266	SPINEART SA	Plan-les-Ouates Geneve, CH
3038187464	MIRACLUS ORTHOTECH PRIVATE LIMITED	Ahmedabad Gujarat, IN
3002808227	SOR VAN RADIATION LTD	Yavne Tel Aviv, IL
1833986	PRECISION EDGE SURGICAL PRODUCTS COMPANY	Sault Sainte Marie, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1226191. Last updated year: 2026. Please use registration number 1226191 when referencing this establishment in official correspondence.