FDA Product Code
FDA Product Code NQP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3070
510(k) Clearances — 22 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203678 | CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021-01-15 | Special | PDF ↗ |
| K191066 | CD Horizon Astute Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019-10-03 | Traditional | PDF ↗ |
| K182928 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019-01-11 | Traditional | PDF ↗ |
| K133164 | DYNESYS TOP-LOADING SPINAL SYSTEM | Zimmer Spine, Inc. | 2014-01-16 | Traditional | PDF ↗ |
| K101704 | ZIMMER DTO PIN PRESS INSTRUMENT | Zimmer Spine, Inc. | 2010-08-18 | Special | PDF ↗ |
| K101083 | DSS STABILIZATION SYSTEM | Paradigm Spine, LLC | 2010-07-02 | Special | PDF ↗ |
| K092234 | DYNESYS TOP-LOADING SPINAL SYSTEM | Zimmer Spine, Inc. | 2009-10-01 | Traditional | PDF ↗ |
| K091944 | MODIFICATION TO: DSS STABILIZATION SYSTEM | Paradigm Spine, LLC | 2009-08-03 | Special | PDF ↗ |
| K073439 | TRANSITION STABILIZATION SYSTEM | Globus Medical, Inc. | 2009-02-20 | Traditional | PDF ↗ |
| K080241 | DDS STABILIZATION SYSTEM | Paradigm Spine, LLC | 2008-11-28 | Traditional | PDF ↗ |
| K080963 | DSS STABILIZATION SYSTEM | Paradigm Spine | 2008-05-02 | Special | PDF ↗ |
| K071261 | ISOBAR SEMI-RIGID DUAL DAMPENER | Scient'X | 2008-04-17 | Traditional | PDF ↗ |
| K072321 | BIOFLEX | Biospine Co., Ltd. | 2008-03-25 | Traditional | PDF ↗ |
| K073347 | DYNESYS TOP-LOADING SPINAL SYSTEM | Zimmer Spine, Inc. | 2008-02-08 | Traditional | PDF ↗ |
| K072969 | DSS | Paradigm Spine, LLC | 2008-01-24 | Traditional | PDF ↗ |
| K072685 | NGARDE SYSTEM | N Spine, Inc. | 2007-10-19 | Special | PDF ↗ |
| K071879 | ZIMMER DTO IMPLANT | Zimmer Spine, Inc. | 2007-10-05 | Traditional | PDF ↗ |
| K061774 | NFIX II PEDICLE SCREW SYSTEM | N Spine, Inc. | 2006-12-13 | Traditional | PDF ↗ |
| K061304 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2006-07-18 | Traditional | PDF ↗ |
| K060638 | DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS | Zimmer Spine, Inc. | 2006-04-06 | Special | PDF ↗ |
| K043565 | MODIFICATION TO DYNESYS SPINAL SYSTEM | Zimmer Spine, Inc. | 2005-03-11 | Special | PDF ↗ |
| K031511 | DYNESYS SPINAL SYSTEM | Centerpulse Spine-Tech, Inc. | 2004-03-05 | Traditional | PDF ↗ |
Product code NQP · Class II · Orthopedic. Data: openFDA.