FDA Product Code
FDA Product Code JDC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3150
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K181362 | TEMA Elbow System | Lima Corporate S.P.A. | 2019-02-16 | Traditional | PDF ↗ |
| K181307 | Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow | Zimmer, Inc. | 2019-01-28 | Traditional | PDF ↗ |
| K153398 | Comprehensive SRS/Nexel Elbow | Biomet Manufacturing Corp | 2016-02-03 | Traditional | PDF ↗ |
| K150501 | Zimmer Nexel Total Elbow Ulnar Cement Diverter | Zimmer, Inc. | 2015-04-23 | Traditional | PDF ↗ |
| K123862 | ZIMMER NEXEL TOTAL ELBOW | Zimmer, Inc. | 2013-03-12 | Traditional | PDF ↗ |
| K090473 | DISCOVERY ELBOW - X-SMALL | Biomet Manufacturing Corp | 2009-03-25 | Special | PDF ↗ |
| K060696 | ACCLAIM TOTAL ELBOW SYSTEM | DePuy Orthopaedics, Inc. | 2006-04-14 | Special | PDF ↗ |
| K053189 | COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES | Zimmer, Inc. | 2005-12-09 | Special | PDF ↗ |
| K051975 | POROUS COATED DISCOVERY ELBOW | Biomet, Inc. | 2005-09-06 | Special | PDF ↗ |
| K042664 | LPS UPPER EXTREMITY | Depuy, Inc. | 2004-12-08 | Traditional | PDF ↗ |
| K040389 | COONRAD/MORREY ELBOW CEMENT RESTRICTOR | Zimmer, Inc. | 2004-05-17 | Traditional | PDF ↗ |
| K033280 | DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM | Biomet, Inc. | 2003-12-19 | Traditional | PDF ↗ |
| K013042 | DISCOVERY ELBOW | Biomet Orthopedics, Inc. | 2001-10-10 | Special | PDF ↗ |
| K003253 | BIOMET'S MINIMALLY CONSTRAINED ELBOW | Biomet, Inc. | 2001-01-12 | Traditional | PDF ↗ |
| K000003 | TORNIER TOTAL ELBOW PROSTHESIS | Tornier | 2000-10-02 | Traditional | PDF ↗ |
| K001989 | COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES | Zimmer, Inc. | 2000-07-25 | Special | PDF ↗ |
| K000683 | MODIFIED SINGLE AXLE TOTAL ELBOW | Biomet, Inc. | 2000-06-27 | Special | PDF ↗ |
| K992656 | DEPUY TOTAL ELBOW SYSTEM | DePuy Orthopaedics, Inc. | 1999-11-05 | Traditional | PDF ↗ |
| K983036 | SINGLE AXLE TOTAL ELBOW | Biomet, Inc. | 1999-04-30 | Traditional | PDF ↗ |
| K982398 | BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW | Biomet, Inc. | 1998-08-11 | Traditional | PDF ↗ |
| K980502 | OSTEONICS TOTAL ELBOW SYSTEM | Osteonics Corp. | 1998-05-05 | Traditional | PDF ↗ |
| K980428 | BIOMET BIAXIAL TOTAL ELBOW | Biomet, Inc. | 1998-05-05 | Traditional | PDF ↗ |
| K973357 | COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN | Zimmer, Inc. | 1998-03-02 | Traditional | PDF ↗ |
| K955916 | TOWNLEY TOTAL ELBOW SYSTEM | Biologically Oriented Prostheses | 1996-08-08 | Traditional | PDF ↗ |
| K901581 | GSB ELBOW | Allo Pro Corp. | 1990-10-22 | Traditional | PDF ↗ |
| K904021 | PNEUMOTHORAX KIT, MODIFICATION | Arrow Intl., Inc. | 1990-10-09 | Traditional | PDF ↗ |
| K883665 | COONRAD III TOTAL ELBOW | Zimmer, Inc. | 1989-02-03 | Traditional | PDF ↗ |
| K872084 | POROCOAT MARK II TOTAL ELBOW | Depuy, Inc. | 1987-06-25 | Traditional | PDF ↗ |
| K861680 | OSTEONICS ELBOW PROSTHESIS | Osteonics Corp. | 1986-06-27 | Traditional | PDF ↗ |
Product code JDC · Class II · Orthopedic. Data: openFDA.