KWH — Prosthesis, Toe, Constrained, Polymer Class II
FDA Device Classification
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 |