OSTEOTEC SILICONE FINGER IMPLANT
OSTEOTEC LTD
OSTEOTECH, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2249915 | 3002600221 | OSTEOTECH, INC. | 1 | N | 2026-01-01 | 201 Industrial Way West EATONTOWN NJ US 07724 |
| 3008395366 | 3008395366 | OSTEOTEC LIMITED | 1 | N | 2026-01-01 | Building 81 Greenham Business Park Newbury West Berkshire GB RG19 6HW |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 135335 | 1332459093 | K151543 | Graft Delivery Device with Integrated Stylet | FMF | 2015-07-07 |
| 117243 | 1084419605 | K140453 | OSTEOTEC SILICONE FINGER IMPLANT | KYJ | 2015-04-17 |
| 135335 | 1320990027 | K122513 | CLEARED UNDER GRAFTON II EDBM | MBP | 2013-03-06 |
| 135335 | 1451284679 | K082615 | GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES | MQV | 2008-10-16 |
| 135335 | 1720678640 | K081227 | PLEXUR M | MQV | 2008-07-22 |
| 135335 | 1669810962 | K080511 | PLEXUR-P | MQV | 2008-04-21 |
| 135335 | 1336303414 | K073405 | PLEXUR M | MQV | 2008-03-03 |
| 135335 | 1865803992 | K061982 | PLEXUR P | MBP | 2007-02-07 |
| 135335 | 1992208888 | K053098 | OPTIUM DBM GEL AND PUTTY | MBP | 2005-11-28 |
| 135335 | 1732490980 | K051195 | GRAFTON DBM | MBP | 2005-12-16 |
| 135335 | 1342724318 | K051188 | GRAFTON DBM | NUN | 2006-01-03 |
| 135335 | 2023798634 | K043048 | GRAFTON PLUS DBM PASTE | MBP | 2005-11-23 |
| 135335 | 1413231190 | K042707 | GRAFTON PLUS DBM PASTE | NUN | 2005-11-30 |
| 117243 | 1057431255 | ||||
| 117243 | 1203062254 | ||||
| 117243 | 1312670747 | ||||
| 117243 | 1590304475 | ||||
| 117243 | 1611959583 | ||||
| 117243 | 1759119120 | ||||
| 117243 | 1062159961 | ||||
| 117243 | 1148384543 |
Product Codes Associated With Registrations#
PMN#
GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES
OSTEOTECH INC
PLEXUR M
OSTEOTECH, INC.
PLEXUR-P
OSTEOTECH, INC.
PLEXUR M
OSTEOTECH, INC.
PLEXUR P
OSTEOTECH, INC.
GRAFTON DBM
OSTEOTECH, INC.
GRAFTON DBM
OSTEOTECH, INC.
GRAFTCAGE TLX
OSTEOTECH, INC.
VIAGRAF DBM PASTE
OSTEOTECH, INC.
GRAFTCAGE ACX
OSTEOTECH, INC.
GRAFTON PLUS DBM PASTE
OSTEOTECH, INC.
GRAFTON PLUS DBM PASTE
OSTEOTECH, INC.
VBR
OSTEOTECH, INC.
VERTEBRAL BODY REPLACEMENT
OSTEOTECH, INC.
VERSALINK TITANIUM ROD-TO-ROD COUPLERS
OSTEOTECH, INC.
VERSALOK LOW BACK FIXATION SYSTEM
OSTEOTECH, INC.
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
OSTEOTECH, INC.
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
OSTEOTECH, INC.
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
OSTEOTECH, INC.
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
OSTEOTECH, INC.
OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS
OSTEOTECH, INC.
OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK
OSTEOTECH, INC.
ALLOPREP SYSTEM
OSTEOTECH, INC.
OSTEOGRAF 2040 OSTEOGRAF 4060
OSTEOTECH, INC.
GUDID#
Osteotec SFI Instruments - The 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.
2025-11-26
Osteotec SFI Sizer - The Osteotec SFI Sizer device comprises of eleven evenly scaled sizers, numbered from size 00 to size 9, to match the available sizes of the definitive implant, the Osteotec Silicone Finger Implant. These eleven sizes effectively constitute components of the Osteotec SFI Sizer, which is placed on the market as a single medical device.Each individual sizer is comprised of a blue flexible silicone elastomer. The sizers are used initially as a guide to choosing the correct size of implant and then, once that choice is made, to insert into the prepared joint space to enable the surgeon to check fit and function e.g. range of motion.
2025-11-26
Osteotec Silicone Finger Implant - Size 00 - 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.
2022-02-04
Osteotec Silicone Finger Implant - Size 0 - 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.
2022-02-04
Osteotec Silicone Finger Implant - Size 1 - 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.
2022-02-04
Osteotec Silicone Finger Implant - Size 2 - 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.
2022-02-04
Osteotec Silicone Finger Implant - Size 3 - 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.
2022-02-04
Osteotec Silicone Finger Implant - Size 4 - 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.
2022-02-04
Osteotec Silicone Finger Implant - Size 5 - 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.
2022-02-04
Osteotec Silicone Finger Implant - Size 6 - 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.
2022-02-04
Osteotec Silicone Finger Implant - Size 7 - 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.
2022-02-04
Osteotec Silicone Finger Implant - Size 8 - 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.
2022-02-04
Osteotec Silicone Finger Implant - Size 9 - 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.
2022-02-04
Osteotec CBG Tube Saw S - size 1 - The 8 tube saws, ranging from 6.5mm Outside Diameter to 17mm Outside Diameter, are sized so that the inside diameter of the larger saw will cut a dowel that will compression fit into the hole formed by the outer diameter of the next size down. The saws and the accompanying instrumentation will allow accurate removal of damaged arthritic bone and insertion of a healthy bone dowel to encourage fusion.
2022-02-04
Osteotec CBG Tube Saw S - size 2 - The 8 tube saws, ranging from 6.5mm Outside Diameter to 17mm Outside Diameter, are sized so that the inside diameter of the larger saw will cut a dowel that will compression fit into the hole formed by the outer diameter of the next size down. The saws and the accompanying instrumentation will allow accurate removal of damaged arthritic bone and insertion of a healthy bone dowel to encourage fusion.
2022-02-04
Osteotec CBG Tube Saw S - size 3 - The 8 tube saws, ranging from 6.5mm Outside Diameter to 17mm Outside Diameter, are sized so that the inside diameter of the larger saw will cut a dowel that will compression fit into the hole formed by the outer diameter of the next size down. The saws and the accompanying instrumentation will allow accurate removal of damaged arthritic bone and insertion of a healthy bone dowel to encourage fusion.
2022-02-04
Osteotec CBG Tube Saw S - size 4 - The 8 tube saws, ranging from 6.5mm Outside Diameter to 17mm Outside Diameter, are sized so that the inside diameter of the larger saw will cut a dowel that will compression fit into the hole formed by the outer diameter of the next size down. The saws and the accompanying instrumentation will allow accurate removal of damaged arthritic bone and insertion of a healthy bone dowel to encourage fusion.
2022-02-04
Osteotec CBG Tube Saw L - size 5 - The 8 tube saws, ranging from 6.5mm Outside Diameter to 17mm Outside Diameter, are sized so that the inside diameter of the larger saw will cut a dowel that will compression fit into the hole formed by the outer diameter of the next size down. The saws and the accompanying instrumentation will allow accurate removal of damaged arthritic bone and insertion of a healthy bone dowel to encourage fusion.
2022-02-04
Osteotec CBG Tube Saw L - size 6 - The 8 tube saws, ranging from 6.5mm Outside Diameter to 17mm Outside Diameter, are sized so that the inside diameter of the larger saw will cut a dowel that will compression fit into the hole formed by the outer diameter of the next size down. The saws and the accompanying instrumentation will allow accurate removal of damaged arthritic bone and insertion of a healthy bone dowel to encourage fusion.
2022-02-04
Osteotec CBG Tube Saw L - size 7 - The 8 tube saws, ranging from 6.5mm Outside Diameter to 17mm Outside Diameter, are sized so that the inside diameter of the larger saw will cut a dowel that will compression fit into the hole formed by the outer diameter of the next size down. The saws and the accompanying instrumentation will allow accurate removal of damaged arthritic bone and insertion of a healthy bone dowel to encourage fusion.
2022-02-04
Osteotec CBG Tube Saw L - size 8 - The 8 tube saws, ranging from 6.5mm Outside Diameter to 17mm Outside Diameter, are sized so that the inside diameter of the larger saw will cut a dowel that will compression fit into the hole formed by the outer diameter of the next size down. The saws and the accompanying instrumentation will allow accurate removal of damaged arthritic bone and insertion of a healthy bone dowel to encourage fusion.
2022-02-04
Osteotec Silicone Finger - Osteotec All In One Silicone Finger Set - Tray of Osteotec Silicone Finger Sizers and Instruments
2024-01-03
Chiroklip wire protector 2 pack blister/box with 25 blisters - ChiroKlip is a small butterfly shaped aluminium clip with an adhesive foam covering. It is designed to fold around the end of a K wire and to safely protect the wearer from the risk of injury or re-injury through catching the sharp end of the K wire on clothing, bedclothes, people or other objects.Each Chiroklip box contain 25 Chiroklip pairs
2022-02-04
Osteotec Silicone Finger - Instrument Tray, Empty - Instrument Tray for the Osteotec Silicone Finger Instruments
2022-02-04
Osteotec Silicone Finger - Instrument Tray Metal, Empty - Instrument Tray for the Osteotec Silicone Finger Instruments
2022-02-04
Osteotec Silicone Finger - Small Rasp Tray, empty - Instrument Tray for the Osteotec Silicone Finger Instruments
2022-02-04
Osteotec Silicone Finger - All In One Silicone Finger Tray, empty - Instrument Tray for the Osteotec Silicone Finger Instruments
2022-02-04
Osteotec CBG Tray, empty - Osteotec CBG Instrument Tray, empty
2022-02-04
Osteotec Silicone Finger - Distal Rasp Size 00 - The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem.
2022-02-04
Osteotec Silicone Finger - Proximal Rasp Size 00 - The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem.
2022-02-04
Osteotec Silicone Finger - Distal Rasp Size 0 - The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem.
2022-02-04
Osteotec Silicone Finger - Proximal Rasp Size 0 - The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem.
2022-02-04
Osteotec Silicone Finger - Distal Rasp Size 1 - The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem.
2022-02-04
Osteotec Silicone Finger - Proximal Rasp Size 1 - The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem.
2022-02-04
Osteotec Silicone Finger - Starter Awl - The standard bone awl is required for making the first mark.
2022-02-04
Osteotec Silicone Finger - Distal Rasp Size 2 - The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem.
2022-02-04
Osteotec Silicone Finger - Proximal Rasp Size 2 - The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem.
2022-02-04
Osteotec Silicone Finger - Distal Rasp Size 3 - The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem.
2022-02-04
Osteotec Silicone Finger - Proximal Rasp Size 3 - The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem.
2022-02-04
Osteotec Silicone Finger - Distal Rasp Size 4 - The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem.
2022-02-04