CONFIDENCE HIGH VISCOSITY BONE CEMENT
FDA 510(k) clearance K060300 · decided 2006-06-21
Clearance details
- K-number
- K060300
- Device name
- CONFIDENCE HIGH VISCOSITY BONE CEMENT
- Applicant
- Disc-O-Tech Medical Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-02-06
- Decision date
- 2006-06-21
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- NDN
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Herzliya, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal C recall (Z-2132-2013) | DePuy Spine, Inc. | 2013-09-03 |
| CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Sp recall (Z-2133-2013) | DePuy Spine, Inc. | 2013-09-03 |
| CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cemen recall (Z-2134-2013) | DePuy Spine, Inc. | 2013-09-03 |
| DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFID recall (Z-0960-2013) | DePuy Spine, Inc. | 2013-03-18 |
| DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFI recall (Z-0961-2013) | DePuy Spine, Inc. | 2013-03-18 |
| DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of recall (Z-0962-2013) | DePuy Spine, Inc. | 2013-03-18 |
| DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENC recall (Z-0963-2013) | DePuy Spine, Inc. | 2013-03-18 |