FDA Product Code
FDA Product Code NDN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3027
510(k) Clearances — 108 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K043406 | VERTEBROPLASTIC RADIOPAQUE BONE CEMENT | Depuy Spine, Inc. | 2005-07-15 | Traditional | PDF ↗ |
| K050864 | PARALLAX ACRYLIC RESIN WITH TRACERS TA | Arthrocare Corp. | 2005-06-17 | Traditional | PDF ↗ |
| K042415 | MENDEC SPINE | Tecres S.P.A. | 2005-06-09 | Traditional | PDF ↗ |
| K043518 | RADIOPAQUE BONE CEMENT | Cardinalhealth | 2005-05-11 | Traditional | PDF ↗ |
| K042168 | CONCORD Radiopaque Bone Cement | Globus Medical, Inc. | 2005-01-14 | Traditional | PDF ↗ |
| K042947 | PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003 | Arthrocare Corp. | 2004-12-27 | Traditional | PDF ↗ |
| K041584 | KYPHX HV-R BONE CEMENT, MODEL C01A | Kyphon, Inc. | 2004-07-07 | Traditional | PDF ↗ |
| K033801 | KYPHX HV-R, MODEL C01A | Kyphon, Inc. | 2004-04-01 | Traditional | PDF ↗ |
Product code NDN · Class II · Orthopedic. Data: openFDA.