Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1226425

FEI Number

3003018882

Entity Name

TECOMET

City/State/Country

Woburn, MA, US

Establishment Address

170 New Boston Street, Woburn, MA 01801, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tecomet (Owner Number: 10031319)

Owner / Operator Contact Address

170 New Boston Street, Woburn, MA 01801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TiMesh Titanium Mini-Softplate/Screw and Micro-Softplate/Screw system Cranialplasty Synthes Radial Head Prothesis A. L. P. S. Clavicle Plating System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEY	Plate, Bone	Dental	Class 2	872.4760	2017-05-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-05-01
JEY	Plate, Bone	Dental	Class 2	872.4760	2017-05-01
JEY	Plate, Bone	Dental	Class 2	872.4760	2017-05-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-05-01
JEY	Plate, Bone	Dental	Class 2	872.4760	2017-05-01
JEY	Plate, Bone	Dental	Class 2	872.4760	2013-01-25
HWT	Template	Orthopedic	Class 1	888.4800	2013-03-01
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2017-05-01
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2013-02-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2010-03-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2010-03-25
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	Class 2	882.5320	2017-05-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-03-05
JEY	Plate, Bone	Dental	Class 2	872.4760	2017-05-01
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-24

Official Correspondent

Brian Sand

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tecomet

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1225675	Tecomet Inc.	Wilmington, MA, US
3003791208	SYMMETRY MEDICAL MANUFACTURING INC.	Lansing, MI, US
3005226664	Tecomet, Inc.	Wilmington, MA, US
3004196040	SYMMETRY MEDICAL THORNTON PRECISION COMPONENTS LTD	SHEFFIELD, SOUTH YORKSHIRE Barnsley, GB
1221053	SYMMETRY MEDICAL, INC. - MANCHESTER	MANCHESTER, NH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K172572	Stryker	Stryker Upper-Face AXS screws and Mid-Face AXS screws	2017-10-31
K121589	Biomet Microfixation	BIOMET MICROFIXATION FACIAL PLATING SYSTEM	2012-09-21
K984230	Osteogenics Biomedical, Inc.	OSTEO-MESH TM-300	1999-02-04
K021618	Osteomed Corp.	OSA RIGID INTERNAL FIXATION SYSTEM	2002-08-08
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2007	Bioplate Inc	2	Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0005-2023	Wright Medical Technology, Inc.	2	stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
Z-0006-2023	Wright Medical Technology, Inc.	2	stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3017734069	REOSS GMBH	Filderstadt Baden-Wurttemberg, DE
1032347	BIOMET MICROFIXATION	Jacksonville, FL, US
3011423165	KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.	Xi'an Shaanxi, CN
2029275	Sterigenics U.S., LLC	Corona, CA, US
3006017180	BBF STERILISATIONSSERVICE GMBH	Kernen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1226425. Last updated year: 2026. Please use registration number 1226425 when referencing this establishment in official correspondence.