FDA Product Code
FDA Product Code OSH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3070
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K153446 | OLYMPIC Posterior Spinal Fixation System | Astura Medical | 2016-04-08 | Traditional | PDF ↗ |
| K140276 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2014-03-13 | Traditional | PDF ↗ |
| K132574 | PASS LP SPINAL SYSTEM | Medicrea International | 2013-11-08 | Traditional | PDF ↗ |
| K132303 | IMPLANET SPINE SYSTEM | Implanet, S.A. | 2013-10-10 | Traditional | PDF ↗ |
| K132575 | PASS LP SPINAL SYSTEM | Medicrea International | 2013-10-03 | Special | PDF ↗ |
| K131802 | EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM | Depuy Spine, A Johnson & Johnson Company | 2013-09-12 | Special | PDF ↗ |
| K131615 | POLARIS SPINAL SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2013-09-04 | Traditional | PDF ↗ |
| K131784 | RANGE SPINAL SYSTEM | K2m, Inc. | 2013-08-30 | Special | PDF ↗ |
| K131321 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek USA | 2013-06-05 | Special | PDF ↗ |
| K124058 | CREO STABILIZATION SYSTEM | Globus Medical, Inc. | 2013-05-13 | Traditional | PDF ↗ |
| K131030 | RANGE SPINAL SYSTEM | K2m, Inc. | 2013-05-09 | Special | PDF ↗ |
| K130655 | RESPONSE SPINE SYSTEM | OrthoPediatrics Corp. | 2013-05-08 | Traditional | PDF ↗ |
| K122877 | RANGE SPINAL SYSTEM, SMALL STATURE | K2m, Inc. | 2013-05-08 | Special | PDF ↗ |
| K130330 | RANGE SPINAL SYSTEM | K2m, Inc. | 2013-05-02 | Special | PDF ↗ |
| K123412 | RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS | K2m, Inc. | 2013-02-13 | Special | PDF ↗ |
| K123138 | PASS LP SPINAL SYSTEM | Medicrea International | 2013-02-05 | Traditional | PDF ↗ |
| K121630 | RANGE SPINAL SYSTEM | K2m, Inc. | 2012-09-11 | Traditional | PDF ↗ |
| K121250 | OP SPINE SYSTEM | OrthoPediatrics Corp. | 2012-06-19 | Special | PDF ↗ |
| K120291 | OP SPINE SYSTEM | OrthoPediatrics Corp. | 2012-04-16 | Traditional | PDF ↗ |
Product code OSH · Class II · Orthopedic. Data: openFDA.