Product code KWH
- Device name
- Prosthesis, Toe, Constrained, Polymer
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3720
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191966 | NewPrim System | Brm Extremities | 2020-02-13 |
| K190136 | Fusion Silastic System | Fusion Orthopedics, LLC | 2019-10-21 |
| K173491 | RTS Lesser MTP Implant System | In2bones USA, LLC | 2018-02-23 |
| K153609 | RTS Flexible 1 MPJ Implant w/Grommets | In2bones USA, LLC | 2016-09-08 |
| K102601 | ORTHOFLEX ROD | Ortho-Pro, LLC | 2011-01-14 |
| K023531 | LESSER METATARSAL PHALANGEAL JOINT IMPLANT | Nexa Orthopedics, Inc. | 2003-01-17 |
| K022887 | INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | Osteomed Corp. | 2002-11-26 |
| K022886 | METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | Osteomed Corp. | 2002-11-25 |
| K023562 | MODIFICATION TO CLASSIC GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | 2002-11-13 |
| K023086 | CLASSIC GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | 2002-10-04 |
| K994326 | ASCENT KNEE SYSTEM | Biomet Manufacturing, Inc. | 2000-01-07 |
| K981194 | FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | 1998-06-30 |
| K946236 | PROFIX CONFORMING PLUS TIBIAL INSERT | Smith & Nephew Richards, Inc. | 1995-07-06 |
| K943354 | SUTTER HAMMERTOE JOINT PROSTHESIS | Sutter Corp. | 1995-06-12 |
| K905795 | SGARLATO FLEXIBLE HINGE TOE IMPLANT | Sgarlato Laboratories, Inc. | 1991-05-29 |
| K884739 | SGARLATO LESSER TOE IMPLANT | Sgarlato Laboratories, Inc. | 1989-05-18 |
| K823405 | ZIMMER GREAT TOE | Zimmer, Inc. | 1983-01-24 |
| K820813 | LESSER METATARSAL PHALANG. JOINT PROSTH | Sutter Biomedical, Inc. | 1982-05-21 |
| K801345 | KAMPNER HINGED TOE PROSTHESIS | Biomedics | 1980-07-08 |
| K801094 | SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL | Dow Corning Corp. Healthcare Industries Materials | 1980-06-09 |
| K780132 | IMPLANT, HINGE TOE, FLEX. | Dow Corning Corp. Healthcare Industries Materials | 1978-02-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00819034028818 | Sgarlato Silastic | FUSION ORTHOPEDICS, LLC | 2020-11-19 |
| 00819034028801 | Sgarlato Silastic | FUSION ORTHOPEDICS, LLC | 2020-11-19 |
| 00880304513778 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304515314 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304515277 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304515253 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304514614 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304514508 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304514461 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304514416 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304514393 | TAPERLOC COMPLETE MICRO PRIMARY FEMORAL | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304514379 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304514355 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304514331 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304514294 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304264618 | ASCENT KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304513655 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304513631 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304513617 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304513594 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304513556 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304513532 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304513518 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304513495 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304513471 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304513457 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304513433 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304512993 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304512979 | Taperloc Complete Micro Primary Femoral | Biomet Orthopedics, LLC | 2015-10-24 |
| 00880304264687 | ASCENT KNEE SYSTEM | Biomet Orthopedics, LLC | 2015-10-24 |