PNEUMOTHORAX KIT, MODIFICATION
FDA 510(k) clearance K904021 · decided 1990-10-09
Clearance details
- K-number
- K904021
- Device name
- PNEUMOTHORAX KIT, MODIFICATION
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-29
- Decision date
- 1990-10-09
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- JDC
- Device class
- 2
- Regulation number
- 888.3150
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TEMA Elbow System (K181362) | Lima Corporate S.P.A. | 2019-02-16 |
| Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow (K181307) | Zimmer, Inc. | 2019-01-28 |
| Comprehensive SRS/Nexel Elbow (K153398) | Biomet Manufacturing Corp | 2016-02-03 |
| Zimmer Nexel Total Elbow Ulnar Cement Diverter (K150501) | Zimmer, Inc. | 2015-04-23 |
| ZIMMER NEXEL TOTAL ELBOW (K123862) | Zimmer, Inc. | 2013-03-12 |
| DISCOVERY ELBOW - X-SMALL (K090473) | Biomet Manufacturing Corp | 2009-03-25 |
| ACCLAIM TOTAL ELBOW SYSTEM (K060696) | DePuy Orthopaedics, Inc. | 2006-04-14 |
| COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES (K053189) | Zimmer, Inc. | 2005-12-09 |
| POROUS COATED DISCOVERY ELBOW (K051975) | Biomet, Inc. | 2005-09-06 |
| LPS UPPER EXTREMITY (K042664) | Depuy, Inc. | 2004-12-08 |
| COONRAD/MORREY ELBOW CEMENT RESTRICTOR (K040389) | Zimmer, Inc. | 2004-05-17 |
| DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM (K033280) | Biomet, Inc. | 2003-12-19 |
Recalls involving this device
No recalls on record reference this clearance.