FDA Product Code
FDA Product Code JDB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3160
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K222807 | TEMA Elbow system - Line extension | Lima Corporate S.P.A. | 2022-10-26 | Traditional | PDF ↗ |
| K193247 | LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. | 2020-08-05 | Traditional | PDF ↗ |
| K182461 | LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. | 2018-12-27 | Traditional | PDF ↗ |
| K171010 | Latitude EV Total Elbow Arthroplasty | Tornier, Inc. | 2017-08-31 | Traditional | PDF ↗ |
| K102180 | RHEAD RADIAL HEAD EXTENDED STEMS | Small Bone Innovations, Inc. | 2010-12-20 | Traditional | PDF ↗ |
| K100562 | LATITUDE ELBOW PROSTHESIS | Tornier, Inc. | 2010-06-29 | Special | PDF ↗ |
| K070787 | LATITUDE ELBOW PROTHESIS | Tornier | 2007-08-24 | Special | PDF ↗ |
| K070236 | SBI LATERAL RADIO CAPITELLUM | Small Bone Innovations, Inc. | 2007-02-21 | Special | PDF ↗ |
| K060438 | RHS | Tornier | 2006-04-18 | Traditional | PDF ↗ |
| K060038 | SBI RADIO-CAPITELLAR IMPLANT | Small Bone Innovations, Inc. | 2006-03-30 | Traditional | PDF ↗ |
| K050848 | TORNIER ELBOW PROSTHESIS | Tornier | 2005-07-14 | Traditional | PDF ↗ |
| K031218 | MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS | Tornier | 2003-05-16 | Special | PDF ↗ |
| K011567 | TORNIER TOTAL ELBOW PROSTHESIS | Tornier | 2001-06-19 | Special | PDF ↗ |
| K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | Johnson & Johnson Professionals, Inc. | 1998-11-06 | Traditional | PDF ↗ |
| K972691 | ABC TOTAL ELBOW PROTHESIS | Biomet, Inc. | 1997-10-15 | Traditional | PDF ↗ |
| K960087 | SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) | Wrightmedicaltechnologyinc | 1996-09-20 | Traditional | PDF ↗ |
| K955099 | SORBIE TOTAL ELBOW SYSTEM | Wrightmedicaltechnologyinc | 1996-02-05 | Traditional | PDF ↗ |
| K880188 | SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM | Howmedica Corp. | 1988-03-01 | Traditional | PDF ↗ |
| K873660 | ROPER-TUKE ELBOW | Orthopedic Systems, Inc. | 1988-01-06 | Traditional | PDF ↗ |
| K823473 | POROCOAT MARK IV ELBOW | Depuy, Inc. | 1983-01-20 | Traditional | PDF ↗ |
| K820957 | SUFACE REPLACEMENT ELBOW | Howmedica Corp. | 1982-07-02 | Traditional | PDF ↗ |
| K812322 | ARIZONA RADIO CAPITELLAR TOTAL ELBOW | Zimmer, Inc. | 1982-01-04 | Traditional | PDF ↗ |
| K811451 | RADIAL HEAD PROSTHESIS | Cintor Orthopaedic Div. | 1981-06-09 | Traditional | PDF ↗ |
| K810847 | PRITCHARD SURFACE REPLACEMENT ELBOW | Depuy, Inc. | 1981-05-01 | Traditional | PDF ↗ |
| K802348 | TRIAXIAL | Johnson & Johnson Professionals, Inc. | 1981-02-23 | Traditional | PDF ↗ |
| K802460 | HELFET ELBOW PROSTHESIS | Depuy, Inc. | 1980-11-19 | Traditional | PDF ↗ |
| K801574 | DEPALMA ELBOW | Zimmer, Inc. | 1980-10-31 | Traditional | PDF ↗ |
Product code JDB · Class II · Orthopedic. Data: openFDA.