Panels › Orthopedic › Product code KYJ · Class 2
Prosthesis, Finger, Constrained, Polymer
Regulation 888.3230
0510(k)s in 12 months (14 all time)
0recalls in 12 months (4 all time)
2recalls that name a 510(k)
Top companies in KYJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ascension Orthopedics, Inc. | 3 | 0 |
| Depuy, Inc. | 2 | 0 |
| Osteotec, Ltd. | 1 | 1 |
| Wright Medical Technology, Inc. | 0 | 2 |
| Avanta Orthopaedics, Inc. | 1 | 0 |
| Brm Extremities Srl | 1 | 0 |
| Cutter Laboratories, Inc. | 1 | 0 |
| DePuy Orthopaedics, Inc. | 1 | 0 |
| Farah , Ltd. | 1 | 0 |
| Integra Lifesciences Sales Llc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2025 | Osteotec Limited Brand Name: Osteotec
Product Name: Osteotec Silicone Finger Implant
Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5)
Software Version: N/A
Product Description: The Osteotec Silicon Open, Classified |
KYJ | K140453 |
| Nov 4, 2019 | Integra Lifesciences Sales Llc Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage:
The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in Terminated |
KYJ | K082231 |
| Nov 8, 2016 | Wright Medical Technology, Inc. SWANSON FINGER JOINT #2, Part Number 4700002 Terminated |
KYJ | None listed |
| Nov 8, 2016 | Wright Medical Technology, Inc. SWANSON FINGER JOINT #1, Part Number 4700001 Terminated |
KYJ | None listed |
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