Panels › Orthopedic › Product code NDN · Class 2
Cement, Bone, Vertebroplasty
Regulation 888.3027
1510(k)s in 12 months (108 all time)
0recalls in 12 months (86 all time)
51recalls that name a 510(k)
Top companies in NDN
| Company | 510(k)s | Recalls |
|---|---|---|
| Zavation, LLC | 1 | 71 |
| Depuy Spine, Inc. | 2 | 8 |
| Stryker Corp. | 7 | 0 |
| Teknimed Sas | 6 | 1 |
| Arthrocare Corp. | 6 | 0 |
| Medtronic | 5 | 0 |
| Tecres S.P.A. | 5 | 0 |
| Dfine, Inc. | 4 | 0 |
| Disc-O-Tech Medical Technologies, Ltd. | 4 | 0 |
| Medtronic Sofamor Danek | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 15, 2005 | K043406 | VERTEBROPLASTIC RADIOPAQUE BONE CEMENT Depuy Spine, Inc. | NDN |
| Jun 17, 2005 | K050864 | PARALLAX ACRYLIC RESIN WITH TRACERS TA Arthrocare Corp. | NDN |
| Jun 9, 2005 | K042415 | MENDEC SPINE Tecres S.P.A. | NDN |
| May 11, 2005 | K043518 | RADIOPAQUE BONE CEMENT Cardinalhealth | NDN |
| Jan 14, 2005 | K042168 | CONCORD Radiopaque Bone Cement Globus Medical, Inc. | NDN |
| Dec 27, 2004 | K042947 | PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003 Arthrocare Corp. | NDN |
| Jul 7, 2004 | K041584 | KYPHX HV-R BONE CEMENT, MODEL C01A Kyphon, Inc. | NDN |
| Apr 1, 2004 | K033801 | KYPHX HV-R, MODEL C01A Kyphon, Inc. | NDN |
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