Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008395366

FEI Number

3008395366

Entity Name

OSTEOTEC LIMITED

City/State/Country

Newbury West Berkshire, GB

Establishment Address

Building 81, Greenham Business Park, Newbury West Berkshire RG19 6HW, GB

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Osteotec Limited (Owner Number: 10032513)

Owner / Operator Contact Address

Building 81, Greenham Business Park, Newbury, GB-NOTA RG19 6HW, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Osteotec Silicone Finger Implant Chiroklip Osteotec Silicone Finger Rasp CBG Osteotec SFI Instruments Osteotec Silicone Finger Sizer Osteotec SFI Sizers Osteotec Silicone Finger All In One Instrument tray, empty

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYJ	Prosthesis, Finger, Constrained, Polymer	Orthopedic	Class 2	888.3230	2015-09-14
HXQ	Crimper, Pin	Orthopedic	Class 1	888.4540	2020-11-02
HTQ	Broach	Orthopedic	Class 1	888.4540	2010-05-20
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2010-05-20
HWT	Template	Orthopedic	Class 1	888.4800	2010-05-20
OJH	Orthopedic Tray	General, Plastic Surgery	Class 1	878.4800	2020-02-12

Official Correspondent

Edna Kurokawa

US Agent Details

David Medoff Business: TriMed Inc Email: ra@trimedortho.com Phone: (661) 2557406

Related Public Records

Same Entity

Osteotec Limited

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

View Entity Profile →

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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1226544	MILLSTONE MEDICAL OUTSOURCING LLC.	FALL RIVER, MA, US
3008868758	EXEL INC. DBA DHL SUPPLY CHAIN (USA)	Mooresville, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008395366. Last updated year: 2026. Please use registration number 3008395366 when referencing this establishment in official correspondence.