| Primary Device ID | 05060183095793 |
| NIH Device Record Key | 5b6e61d7-88cd-49c9-9e44-06ef12cd17e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Osteotec SFI Instruments |
| Version Model Number | OSTF-Ins |
| Catalog Number | OSTF-Ins |
| Company DUNS | 348489386 |
| Company Name | OSTEOTEC LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060183095793 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05060183095793]
Moist Heat or Steam Sterilization
[05060183095793]
Moist Heat or Steam Sterilization
[05060183095793]
Moist Heat or Steam Sterilization
[05060183095793]
Moist Heat or Steam Sterilization
[05060183095793]
Moist Heat or Steam Sterilization
[05060183095793]
Moist Heat or Steam Sterilization
[05060183095793]
Moist Heat or Steam Sterilization
[05060183095793]
Moist Heat or Steam Sterilization
[05060183095793]
Moist Heat or Steam Sterilization
[05060183095793]
Moist Heat or Steam Sterilization
[05060183095793]
Moist Heat or Steam Sterilization
[05060183095793]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-04 |
| Device Publish Date | 2025-11-26 |
| 05060183095793 - Osteotec SFI Instruments | 2025-12-04The Osteotec SFI Instruments device are a non-active, non-implantable, invasive device intended to be used as a tool for creating the correct size of cavity in the medullary canal to enable implantation of the Osteotec Silicone Finger Implant prosthesis during arthroplasty to replace the metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The Osteotec SFI Instruments are available in eleven evenly scaled sizes, numbered from size 00 to size 9, to match the available sizes of the definitive implant, the Osteotec Silicone Finger Implant. Each size has 2 rasps, one for creation of the proximal cavity and one for the distal cavity, therefore 22 rasps in total. The instrument set also includes an Awl, this creates an initial indent for the rasps to open up in stages. These eleven sizes and the Awl effectively constitute components of the Osteotec SFI Instruments, which is placed on the market as a single medical device. |
| 05060183095793 - Osteotec SFI Instruments | 2025-12-04 The Osteotec SFI Instruments device are a non-active, non-implantable, invasive device intended to be used as a tool for creatin |
| 05060183095809 - Osteotec SFI Sizer | 2025-12-04 The Osteotec SFI Sizer device comprises of eleven evenly scaled sizers, numbered from size 00 to size 9, to match the available |
| 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 |