Data / Medical devices / United Kingdom / Osteotec Limited

Osteotec Limited: FDA-registered device maker in Newbury West Berkshire, United Kingdom, 1 510(k) clearance

Name: Osteotec Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Osteotec Limited is registered with the FDA (registration 3008395366) in Newbury West Berkshire, United Kingdom. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 17, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008395366
Address: Building 81 Greenham Business Park, Newbury West Berkshire, United Kingdom, RG19 6HW
Owner or operator: Osteotec Limited (10032513)
Roles: Exporter to the US, Specification developer
First device listed: May 20, 2010
Registered through: 2026
Brand names listed: CBG, Chiroklip, Osteotec SFI Instruments, Osteotec SFI Sizers, Osteotec Silicone Finger All In One Instrument tray, Osteotec Silicone Finger All In One Instrument tray, empty, Osteotec Silicone Finger Awl, Osteotec Silicone Finger Implant and more

Devices it lists

Device	Product code	Class	Role	Source
Awl	HWJ	1	Exporter to the US, Specification developer	accessdata.fda.gov
Broach	HTQ	1	Exporter to the US, Specification developer	accessdata.fda.gov
Crimper, Pin	HXQ	1	Exporter to the US, Specification developer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Exporter to the US, Specification developer	accessdata.fda.gov
Orthopedic Tray	OJH	1	Exporter to the US, Specification developer	accessdata.fda.gov
Prosthesis, Finger, Constrained, Polymer	KYJ	2	Exporter to the US, Specification developer	accessdata.fda.gov
Template	HWT	1	Exporter to the US, Specification developer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Exporter to the US, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 17, 2015	K140453	OSTEOTEC SILICONE FINGER IMPLANT	KYJ	Substantially Equivalent	Osteotec, Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 18, 2025	97126	Class II	Ongoing	Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is	There is the potential that the silicone implant may contain foreign material	accessdata.fda.gov

Compare with other makers

Updated July 31, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.