FDA Product Code
FDA Product Code KWH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3720
510(k) Clearances — 21 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K191966 | NewPrim System | Brm Extremities | 2020-02-13 | Traditional | PDF ↗ |
| K190136 | Fusion Silastic System | Fusion Orthopedics, LLC | 2019-10-21 | Traditional | PDF ↗ |
| K173491 | RTS Lesser MTP Implant System | In2bones USA, LLC | 2018-02-23 | Traditional | PDF ↗ |
| K153609 | RTS Flexible 1 MPJ Implant w/Grommets | In2bones USA, LLC | 2016-09-08 | Traditional | PDF ↗ |
| K102601 | ORTHOFLEX ROD | Ortho-Pro, LLC | 2011-01-14 | Traditional | PDF ↗ |
| K023531 | LESSER METATARSAL PHALANGEAL JOINT IMPLANT | Nexa Orthopedics, Inc. | 2003-01-17 | Traditional | PDF ↗ |
| K022887 | INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | Osteomed Corp. | 2002-11-26 | Traditional | PDF ↗ |
| K022886 | METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | Osteomed Corp. | 2002-11-25 | Traditional | PDF ↗ |
| K023562 | MODIFICATION TO CLASSIC GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | 2002-11-13 | Special | PDF ↗ |
| K023086 | CLASSIC GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | 2002-10-04 | Special | PDF ↗ |
| K994326 | ASCENT KNEE SYSTEM | Biomet Manufacturing, Inc. | 2000-01-07 | Special | PDF ↗ |
| K981194 | FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | 1998-06-30 | Traditional | PDF ↗ |
| K946236 | PROFIX CONFORMING PLUS TIBIAL INSERT | Smith & Nephew Richards, Inc. | 1995-07-06 | Traditional | PDF ↗ |
| K943354 | SUTTER HAMMERTOE JOINT PROSTHESIS | Sutter Corp. | 1995-06-12 | Traditional | PDF ↗ |
| K905795 | SGARLATO FLEXIBLE HINGE TOE IMPLANT | Sgarlato Laboratories, Inc. | 1991-05-29 | Traditional | PDF ↗ |
| K884739 | SGARLATO LESSER TOE IMPLANT | Sgarlato Laboratories, Inc. | 1989-05-18 | Traditional | PDF ↗ |
| K823405 | ZIMMER GREAT TOE | Zimmer, Inc. | 1983-01-24 | Traditional | PDF ↗ |
| K820813 | LESSER METATARSAL PHALANG. JOINT PROSTH | Sutter Biomedical, Inc. | 1982-05-21 | Traditional | PDF ↗ |
| K801345 | KAMPNER HINGED TOE PROSTHESIS | Biomedics | 1980-07-08 | Traditional | PDF ↗ |
| K801094 | SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL | Dow Corning Corp. Healthcare Industries Materials | 1980-06-09 | Traditional | PDF ↗ |
| K780132 | IMPLANT, HINGE TOE, FLEX. | Dow Corning Corp. Healthcare Industries Materials | 1978-02-06 | Traditional | PDF ↗ |
Product code KWH · Class II · Orthopedic. Data: openFDA.