Panels › Orthopedic › Product code KWH · Class 2
Prosthesis, Toe, Constrained, Polymer
Regulation 888.3720
0510(k)s in 12 months (21 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in KWH
| Company | 510(k)s | Recalls |
|---|---|---|
| Nexa Orthopedics, Inc. | 4 | 0 |
| Dow Corning Corp. Healthcare Industries Materials | 2 | 0 |
| In2bones USA, LLC | 2 | 0 |
| Osteomed Corp. | 2 | 0 |
| Sgarlato Laboratories, Inc. | 2 | 0 |
| Biomedics | 1 | 0 |
| Biomet Manufacturing, Inc. | 1 | 0 |
| Brm Extremities | 1 | 0 |
| Fusion Orthopedics, LLC | 1 | 0 |
| Ortho-Pro, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 13, 2020 | K191966 | NewPrim System Brm Extremities | KWH |
| Oct 21, 2019 | K190136 | Fusion Silastic System Fusion Orthopedics, LLC | KWH |
| Feb 23, 2018 | K173491 | RTS Lesser MTP Implant System In2bones USA, LLC | KWH |
| Sep 8, 2016 | K153609 | RTS Flexible 1 MPJ Implant w/Grommets In2bones USA, LLC | KWH |
| Jan 14, 2011 | K102601 | ORTHOFLEX ROD Ortho-Pro, LLC | KWH |
| Jan 17, 2003 | K023531 | LESSER METATARSAL PHALANGEAL JOINT IMPLANT Nexa Orthopedics, Inc. | KWH |
| Nov 26, 2002 | K022887 | INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM Osteomed Corp. | KWH |
| Nov 25, 2002 | K022886 | METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM Osteomed Corp. | KWH |
| Nov 13, 2002 | K023562 | MODIFICATION TO CLASSIC GREAT TOE IMPLANT Nexa Orthopedics, Inc. | KWH |
| Oct 4, 2002 | K023086 | CLASSIC GREAT TOE IMPLANT Nexa Orthopedics, Inc. | KWH |
| Jan 7, 2000 | K994326 | ASCENT KNEE SYSTEM Biomet Manufacturing, Inc. | KWH |
| Jun 30, 1998 | K981194 | FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT Nexa Orthopedics, Inc. | KWH |
| Jul 6, 1995 | K946236 | PROFIX CONFORMING PLUS TIBIAL INSERT Smith & Nephew Richards, Inc. | KWH |
| Jun 12, 1995 | K943354 | SUTTER HAMMERTOE JOINT PROSTHESIS Sutter Corp. | KWH |
| May 29, 1991 | K905795 | SGARLATO FLEXIBLE HINGE TOE IMPLANT Sgarlato Laboratories, Inc. | KWH |
| May 18, 1989 | K884739 | SGARLATO LESSER TOE IMPLANT Sgarlato Laboratories, Inc. | KWH |
| Jan 24, 1983 | K823405 | ZIMMER GREAT TOE Zimmer, Inc. | KWH |
| May 21, 1982 | K820813 | LESSER METATARSAL PHALANG. JOINT PROSTH Sutter Biomedical, Inc. | KWH |
| Jul 8, 1980 | K801345 | KAMPNER HINGED TOE PROSTHESIS Biomedics | KWH |
| Jun 9, 1980 | K801094 | SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL Dow Corning Corp. Healthcare Industries Materials | KWH |
| Feb 6, 1978 | K780132 | IMPLANT, HINGE TOE, FLEX. Dow Corning Corp. Healthcare Industries Materials | KWH |
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