510(k) K060300 ยท NDN Cement, Bone, Vertebroplasty
CONFIDENCE HIGH VISCOSITY BONE CEMENT
| Applicant | Disc-O-Tech Medical Technologies, Ltd., Herzliya, IL |
| Decision | Substantially Equivalent, Jun 21, 2006 |
| Received | Feb 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060300
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2017 | DePuy Spine, Inc. Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630)
The CONFIDENCE SPINAL CEMENT SYSTEM 11cc Kit is intended for per Terminated |
NDN | None listed |
| Sep 3, 2013 | DePuy Spine, Inc. CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000
The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixati Terminated |
NDN | None listed |
| Sep 3, 2013 | DePuy Spine, Inc. CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000
The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for Terminated |
NDN | None listed |
| Sep 3, 2013 | DePuy Spine, Inc. CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000
The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation Terminated |
NDN | None listed |
| Mar 18, 2013 | DePuy Spine, Inc. DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT
Catalog Number:283905000.
Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Terminated |
NDN | None listed |
| Mar 18, 2013 | DePuy Spine, Inc. DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT
Catalog Number: 283907000.
Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Terminated |
NDN | None listed |
| Mar 18, 2013 | DePuy Spine, Inc. DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT
Catalog Number: 283910000.
Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Terminated |
NDN | None listed |
| Mar 18, 2013 | DePuy Spine, Inc. DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT
Catalog Number: 283913000.
Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Terminated |
NDN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.