KWH — Prosthesis, Toe, Constrained, Polymer Class II
FDA product code KWH covers "Prosthesis, Toe, Constrained, Polymer", a Class II medical device regulated under 21 CFR 888.3720. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KWH
- Device Class
- Class II
- Regulation Number
- 888.3720
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K191966 | brm extremities | NewPrim System | February 13, 2020 |
| K190136 | fusion orthopedics | Fusion Silastic System | October 21, 2019 |
| K173491 | in2bones usa | RTS Lesser MTP Implant System | February 23, 2018 |
| K153609 | in2bones usa | RTS Flexible 1 MPJ Implant w/Grommets | September 8, 2016 |
| K102601 | ortho-pro | ORTHOFLEX ROD | January 14, 2011 |
| K023531 | nexa orthopedics | LESSER METATARSAL PHALANGEAL JOINT IMPLANT | January 17, 2003 |
| K022887 | osteomed | INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | November 26, 2002 |
| K022886 | osteomed | METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | November 25, 2002 |
| K023562 | nexa orthopedics | MODIFICATION TO CLASSIC GREAT TOE IMPLANT | November 13, 2002 |
| K023086 | nexa orthopedics | CLASSIC GREAT TOE IMPLANT | October 4, 2002 |
| K994326 | biomet manufacturing | ASCENT KNEE SYSTEM | January 7, 2000 |
| K981194 | nexa orthopedics | FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT | June 30, 1998 |
| K946236 | smith and nephew richards | PROFIX CONFORMING PLUS TIBIAL INSERT | July 6, 1995 |
| K943354 | sutter | SUTTER HAMMERTOE JOINT PROSTHESIS | June 12, 1995 |
| K905795 | sgarlato laboratories | SGARLATO FLEXIBLE HINGE TOE IMPLANT | May 29, 1991 |
| K884739 | sgarlato laboratories | SGARLATO LESSER TOE IMPLANT | May 18, 1989 |
| K823405 | zimmer | ZIMMER GREAT TOE | January 24, 1983 |
| K820813 | sutter biomedical | LESSER METATARSAL PHALANG. JOINT PROSTH | May 21, 1982 |
| K801345 | biomedics | KAMPNER HINGED TOE PROSTHESIS | July 8, 1980 |
| K801094 | dow corning corp. healthcare industries materials | SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL | June 9, 1980 |