Osteotec Silicone Finger Implant - Size 5 OSTF-5

GUDID 05060183090064

The Osteotec Silicone Finger Implant 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.

OSTEOTEC LIMITED

Metacarpophalangeal/proximal interphalangeal joint prosthesis Metacarpophalangeal/proximal interphalangeal joint prosthesis Metacarpophalangeal/proximal interphalangeal joint prosthesis Metacarpophalangeal/proximal interphalangeal joint prosthesis Metacarpophalangeal/proximal interphalangeal joint prosthesis Metacarpophalangeal/proximal interphalangeal joint prosthesis Metacarpophalangeal/proximal interphalangeal joint prosthesis Metacarpophalangeal/proximal interphalangeal joint prosthesis Metacarpophalangeal/proximal interphalangeal joint prosthesis Metacarpophalangeal/proximal interphalangeal joint prosthesis Metacarpophalangeal/proximal interphalangeal joint prosthesis Metacarpophalangeal/proximal interphalangeal joint prosthesis Metacarpophalangeal/proximal interphalangeal joint prosthesis

• Primary Device ID: 05060183090064
• NIH Device Record Key: d80fce3e-439d-4d02-ba2f-a4bc2b36a58c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteotec Silicone Finger Implant - Size 5
• Version Model Number: OSTF-5
• Catalog Number: OSTF-5
• Company DUNS: 348489386
• Company Name: OSTEOTEC LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060183090064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140453

FDA Product Code

• KYJ: Prosthesis, Finger, Constrained, Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-14
• Device Publish Date: 2022-02-04

Devices Manufactured by OSTEOTEC LIMITED

• 05060183095588 - Osteotec Silicone Finger - Osteotec All In One Silicone Finger Set: 2024-01-11 Tray of Osteotec Silicone Finger Sizers and Instruments
• 05060079820355 - Chiroklip wire protector 2 pack blister: 2022-02-14 ChiroKlip is a small butterfly shaped aluminium clip with an adhesive foam covering. It is designed to fold around the end of a
• 05060183090002 - Osteotec Silicone Finger Implant - Size 00: 2022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis
• 05060183090019 - Osteotec Silicone Finger Implant - Size 0: 2022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis
• 05060183090026 - Osteotec Silicone Finger Implant - Size 1: 2022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis
• 05060183090033 - Osteotec Silicone Finger Implant - Size 2: 2022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis
• 05060183090040 - Osteotec Silicone Finger Implant - Size 3: 2022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis
• 05060183090057 - Osteotec Silicone Finger Implant - Size 4: 2022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis