Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005226664

FEI Number

3005226664

Entity Name

Tecomet, Inc.

City/State/Country

Wilmington, MA, US

Establishment Address

301 Ballardvale St, Wilmington, MA 01887, 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

Ti Hard Rod Ti Hard Rod Ti Hard Rod

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-04-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-05-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-05-01
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2017-05-01
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-05-01
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2017-05-01
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-05-01
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2017-05-01
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2017-05-01
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2017-05-01

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
3004196040	SYMMETRY MEDICAL THORNTON PRECISION COMPONENTS LTD	SHEFFIELD, SOUTH YORKSHIRE Barnsley, GB
1226425	TECOMET	Woburn, MA, US
1221053	SYMMETRY MEDICAL, INC. - MANCHESTER	MANCHESTER, NH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03
K062643	Life Spine	KINETIC ANTERIOR CERVICAL PLATE	2006-11-16
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
3009417901	SYNTHES GMBH	Zuchwil Solothurn, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005226664. Last updated year: 2026. Please use registration number 3005226664 when referencing this establishment in official correspondence.