FDA Product Code
FDA Product Code KYI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3770
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 | Ensemble Orthopedics, LLC | 2020-12-02 | Traditional | PDF ↗ |
| K180744 | Stablyx CMC Arthroplasty Implant System | Skeletal Dynamics, LLC | 2018-04-11 | Special | PDF ↗ |
| K111068 | STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 | Skeletal Dynamics, LLC | 2011-12-30 | Traditional | PDF ↗ |
| K112278 | ASCENSION NUGRIP CMC IMPLANT | Ascension Orthopedic | 2011-11-04 | Traditional | PDF ↗ |
| K092548 | EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS | Extremity Medical, LLC | 2009-12-15 | Traditional | PDF ↗ |
| K061956 | ARTELON STT SPACER | Artimplant AB | 2007-06-07 | Traditional | PDF ↗ |
| K061954 | ARTELON CMC SPACER ARTHRO | Artimplant AB | 2007-06-01 | Special | PDF ↗ |
| K061451 | ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 | Ascension Orthopedics, Inc. | 2006-08-11 | Traditional | PDF ↗ |
| K061089 | MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 | Biopro, Inc. | 2006-06-20 | Traditional | PDF ↗ |
| K060386 | NEXA CARPO METACARPAL IMPLANT | Nexa Orthopedics, Inc. | 2006-05-10 | Traditional | PDF ↗ |
| K052596 | MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 | Biopro, Inc. | 2005-11-15 | Traditional | PDF ↗ |
| K042690 | ASCENSION PYROSPHERE (PCS) | Ascension Orthopedics, Inc. | 2004-11-13 | Traditional | PDF ↗ |
| K040070 | ARTELON SPACER CMC-1 | Artimplant AB | 2004-09-21 | Traditional | PDF ↗ |
| K041451 | ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 | Ascension Orthopedics, Inc. | 2004-08-25 | Traditional | PDF ↗ |
| K033529 | TIE-IN TRAPEZIUM | Wrightmedicaltechnologyinc | 2003-12-03 | Special | PDF ↗ |
| K965204 | AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT | Avanta Orthopaedics, Inc. | 1997-06-03 | Traditional | PDF ↗ |
| K960534 | METALLIC SPHERICAL CMC IMPLANT | Wrightmedicaltechnologyinc | 1997-02-06 | Traditional | PDF ↗ |
| K960659 | CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) | Wrightmedicaltechnologyinc | 1997-02-06 | Traditional | PDF ↗ |
| K964472 | RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT | Biologically Oriented Prostheses | 1997-02-03 | Traditional | PDF ↗ |
| K964381 | AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT | Avanta Orthopaedics, Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K951471 | STRICKLAND TRAPEZIAL IMPLANT | Wrightmedicaltechnologyinc | 1995-08-09 | Traditional | PDF ↗ |
| K864489 | SWANSON TITANIUM TRAPEZIUM IMPLANT | Dow Corning Wright | 1987-04-15 | Traditional | PDF ↗ |
| K864488 | SWANSON TITANIUM CONDYLAR IMPLANT | Dow Corning Wright | 1987-04-15 | Traditional | PDF ↗ |
| K801952 | SPINE ALIGN | B.H. Richardson, D.C. | 1980-09-16 | Traditional | PDF ↗ |
| K790508 | TRAPEZIO-METACARPAL JOINT SPACER | Scientific Data Systems Israel, Ltd. | 1979-04-10 | Traditional | PDF ↗ |
| K781756 | SILASTIC H.P. TRAPEXIAL IMPLANT | Dow Corning Corp. Healthcare Industries Materials | 1978-11-15 | Traditional | PDF ↗ |
Product code KYI · Class II · Orthopedic. Data: openFDA.