Duns Number:348489386
Device Description: The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant w 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.
Catalog Number
OSTF-9
Brand Name
Osteotec Silicone Finger Implant - Size 9
Version/Model Number
OSTF-9
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K140453
Product Code
KYJ
Product Code Name
Prosthesis, Finger, Constrained, Polymer
Public Device Record Key
15e437e8-eeab-411c-8bfa-de2c81dfd0a4
Public Version Date
February 14, 2022
Public Version Number
1
DI Record Publish Date
February 04, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |