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Osteotec, Ltd.

Last updated May 24, 2026

What Osteotec, Ltd. makes

Osteotec, Ltd. manufactures reusable orthopaedic instruments and components for hand surgery, including bone files, rasps, and awls designed for distal and proximal phalanges. Their portfolio also includes trial implants, sizers, and holders for metacarpophalangeal and proximal interphalangeal joint prostheses, as well as osteotomy guides and counter-torque instruments for bone manipulation. Additional products feature reusable bone trephines and instrument trays for surgical procedures.

The company’s devices are classified under FDA regulations as Class I and Class II, with submissions recorded in the FDA’s 510(k) and Unique Device Identification (UDI) databases. Their products are intended for use in the United States, where regulatory compliance aligns with FDA requirements for medical device authorisation.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
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EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (70)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Osteotec Silicone Finger - Distal Rasp Size 5	OSTF-5D	FDA UDI	Class I	Active
Osteotec CBG Remover Handle	OST-CBG-26	FDA UDI	Class I	Active
Osteotec CBG Guide L	OST-CBG-25	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant Sizer Size 2	OSTF-S2	FDA UDI	Class I	Active
Osteotec Silicone Finger - Proximal Rasp Size 3	OSTF-3P	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant Sizer Size 7	OSTF-S7	FDA UDI	Class I	Active
Osteotec Silicone Finger - Distal Rasp Size 0	OSTF-0D	FDA UDI	Class I	Active
Osteotec Silicone Finger - Distal Rasp Size 8	OSTF-8D	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant - Size 3	OSTF-3	FDA UDI	Class II	Active
Osteotec Silicone Finger - Proximal Rasp Size 7	OSTF-7P	FDA UDI	Class I	Active
Osteotec CBG Tube Saw L - size 5	OST-CBG-05	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant - Size 5	OSTF-5	FDA UDI	Class II	Active
Osteotec Silicone Finger Implant - Size 00	OSTF-00	FDA UDI	Class II	Active
Osteotec Silicone Finger Implant Sizer Size 1	OSTF-S1	FDA UDI	Class I	Active
Osteotec Silicone Finger - Instrument Tray, Empty	OSTF-INS3	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant Sizer Size 9	OSTF-S9	FDA UDI	Class I	Active
Osteotec CBG Ergonomic Torque Handle	OST-CBG-15	FDA UDI	Class I	Active
Osteotec Silicone Finger - Distal Rasp Size 4	OSTF-4D	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant - Size 6	OSTF-6	FDA UDI	Class II	Active
Osteotec Silicone Finger - Proximal Rasp Size 4	OSTF-4P	FDA UDI	Class I	Active
Osteotec Silicone Finger - Distal Rasp Size 7	OSTF-7D	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant Sizer Size 3	OSTF-S3	FDA UDI	Class I	Active
Osteotec CBG Guide S	OST-CBG-24	FDA UDI	Class I	Active
Osteotec Silicone Finger - Distal Rasp Size 6	OSTF-6D	FDA UDI	Class I	Active
Osteotec Silicone Finger - Osteotec All In One Silicone Finger Set	OSTF-INS9	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant Sizer Size 8	OSTF-S8	FDA UDI	Class I	Active
Osteotec Silicone Finger - Distal Rasp Size 00	OSTF-00D	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant - Size 0	OSTF-0	FDA UDI	Class II	Active
Osteotec CBG Tube Saw S - size 4	OST-CBG-04	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant Sizer Size 4	OSTF-S4	FDA UDI	Class I	Active
Osteotec Silicone Finger - Instrument Tray Metal, Empty	OSTF-INS5	FDA UDI	Class I	Active
Osteotec Silicone Finger - Proximal Rasp Size 0	OSTF-0P	FDA UDI	Class I	Active
Osteotec Silicone Finger - Proximal Rasp Size 2	OSTF-2P	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant - Size 7	OSTF-7	FDA UDI	Class II	Active
Osteotec Silicone Finger Implant Sizer Size 5	OSTF-S5	FDA UDI	Class I	Active
Chiroklip wire protector 2 pack blister/box with 25 blisters	CKB2	FDA UDI	Class I	Active
Osteotec Silicone Finger - Proximal Rasp Size 8	OSTF-8P	FDA UDI	Class I	Active
Osteotec CBG Spike S	OST-CBG-16	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant - Size 9	OSTF-9	FDA UDI	Class II	Active
Osteotec Silicone Finger - Proximal Rasp Size 9	OSTF-9P	FDA UDI	Class I	Active
Osteotec CBG Tube Saw S - size 1	OST-CBG-01	FDA UDI	Class I	Active
Osteotec Silicone Finger - Distal Rasp Size 1	OSTF-1D	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant Sizer Size 0	OSTF-S0	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant - Size 1	OSTF-1	FDA UDI	Class II	Active
Osteotec CBG Ejector S	OST-CBG-18	FDA UDI	Class I	Active
Osteotec CBG Tube Saw S - size 2	OST-CBG-02	FDA UDI	Class I	Active
Osteotec CBG Tube Saw S - size 3	OST-CBG-03	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant Sizer Size 6	OSTF-S6	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant - Size 8	OSTF-8	FDA UDI	Class II	Active
Osteotec Silicone Finger - Starter Awl	OSTF-AWL	FDA UDI	Class I	Active

Related Companies

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Osteotec, Ltd. has one FDA recall record initiated on June 18, 2025. The recall is listed with both open and classified statuses. The reason stated is the potential presence of foreign material in the silicone implant.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jun 18, 2025	Z-2222-2025	—	open, classified	There is the potential that the silicone implant may contain foreign material