Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2132732

FEI Number

1000306694

Entity Name

TECOMET, INC.

City/State/Country

KENOSHA, WI, US

Establishment Address

5307 95th Ave, KENOSHA, WI 53144, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Tecomet (Owner Number: 10031318)

Owner / Operator Contact Address

5307 95th Avenue, Kenosha, WI 53144, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BacFix Ti (Spinal Fixation System) Silhouette (Prototypes) Multiple Surgical Cutters BacFix Ti (Spinal Fixation System) Multiple Screwdrivers Multiple Orthopedic Screwdrivers Beere Medical Bethea Sheet Holder Multiple Manual General Surgical Instruments Sterilization wrap containers, trays, cassettes & other accessories General Surgical Scissors BacFix Ti (Spinal Fixation System) Beere Medical Torque Limiting Adapter Weck Hem-O-Lock Endo Clip Remover Weck Hem-O-Lock Clip Remover InViZia (Anterior Cervical Plate Sys) Beere Medical VIPER PRIME Locking Post Driver Multiple Manual Surgical Chisels Weck Raney Scalp Clip Appliers BAYONETED BALL PROBE 110DEGSHT ROD ROTATION FORCEPS BAYONETED WOODSON PROBE 90DEG BAYONETED WOODSON PROBE 45DEG BAYONETED BALL PROBE 110DEGLNG Multiple Bone Taps Multiple Orthopedic Bone Taps Beere Medical Multiple Wrenches Beere Medical Evolution Broken Screw Remover Multiple Trephines SC - AcuFix (Ant-Cer) Multiple Orthopedic Tamps Multiple Tamps ST360 (Spinal Fixation System) Multiple Awls Multiple Orthopedic Awls Beere Medical BacFix Ti (Spinal Fixation System) Bit, Drill Silhouette (Prototypes) Multiple Bending Plates Multiple Trial Rods Hem-O-Clip Plus Hem-O-Clip Traditional Horizon Hem-O-Lock Beere Medical VOLT Mini Fragment VOLT Small Fragment LUXOR RETRACTOR NERVE ROOT WIDE Retractor RETRACTOR NERVE ROOT NARROW Beere Medical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-09-15
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2012-12-14
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2015-03-30
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-12-18
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-12-21
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2012-12-21
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2012-09-16
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-09-15
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-02-20
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2012-09-16
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2020-09-04
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-09-16
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2012-12-14
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2013-12-18
HTO	Reamer	Orthopedic	Class 1	888.4540	2012-12-14
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2012-12-14
HBQ	Instrument, Clip Removal	Neurology	Class 1	882.4200	2012-09-16
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2012-12-14
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2012-12-21
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2012-09-15
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2012-09-15
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2012-12-21
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2012-09-16
HWA	Impactor	Orthopedic	Class 1	888.4540	2012-12-14
HWB	Extractor	Orthopedic	Class 1	888.4540	2012-12-21
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2017-04-13
HXC	Wrench	Orthopedic	Class 1	888.4540	2012-09-16
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2013-02-20
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2013-02-20
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-02-20
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2012-12-14
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-02-20
HWK	Trephine	Orthopedic	Class 1	888.4540	2012-09-16
HXG	Tamp	Orthopedic	Class 1	888.4540	2012-09-16
HWJ	Awl	Orthopedic	Class 1	888.4540	2012-09-16
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-09-15
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2013-12-18
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2016-01-28
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2012-09-16
HWT	Template	Orthopedic	Class 1	888.4800	2012-09-16
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-12-21
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	2012-09-16
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2012-12-14
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2012-12-21
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2013-12-18
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-12-21
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2013-02-20
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2012-09-15
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2013-02-20

Official Correspondent

Julie Davis

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
1226425	TECOMET	Woburn, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2132732. Last updated year: 2026. Please use registration number 2132732 when referencing this establishment in official correspondence.