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Osteotec Silicone Finger Implant - Size 6

FDA UDI

Class II (US FDA UDI)

by Osteotec, Ltd.

Identity

Trade Name
Osteotec Silicone Finger Implant - Size 6 FDA UDI
Generic Name
Metacarpophalangeal/proximal interphalangeal joint prosthesis FDA UDI
Device Name
The Osteotec Silicone Finger Implant (uncemented) is a one-piece, flexible silicone elastomer implant which is placed in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) finger joints during resection arthroplasty. FDA UDI
Model / Reference
OSTF-6 FDA UDI
Description
The Osteotec Silicone Finger Implant (uncemented) is a one-piece, flexible silicone elastomer implant which is placed in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) finger joints during resection arthroplasty. FDA UDI

Identifiers

Catalog Number
OSTF-6 FDA UDI
Primary DI / UDI-DI
05060183090071 FDA UDI
510(k) Number
K140453 FDA UDI
FDA Product Code
KYJ FDA UDI
GMDN Term
Metacarpophalangeal/proximal interphalangeal joint prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3230 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Metacarpophalangeal/proximal interphalangeal joint prosthesis

Osteotec Silicone Finger Implant - Size 6 by Osteotec, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metacarpophalangeal/proximal interphalangeal joint prosthesis.

Cleared under the same submission

K140453 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osteotec, Ltd.

Sources (1)

  • FDA UDI 9c557e66-2569-41d9-8042-7346c0db6578 35 fields · synced May 30, 2026