OLYMPIC Posterior Spinal Fixation System
FDA 510(k) clearance K153446 · decided 2016-04-08
Clearance details
- K-number
- K153446
- Device name
- OLYMPIC Posterior Spinal Fixation System
- Applicant
- Astura Medical
- Decision
- Substantially Equivalent
- Date received
- 2015-11-27
- Decision date
- 2016-04-08
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- OSH
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CD HORIZON SPINAL SYSTEM (K140276) | Medtronic Sofamor Danek | 2014-03-13 |
| PASS LP SPINAL SYSTEM (K132574) | Medicrea International | 2013-11-08 |
| IMPLANET SPINE SYSTEM (K132303) | Implanet, S.A. | 2013-10-10 |
| PASS LP SPINAL SYSTEM (K132575) | Medicrea International | 2013-10-03 |
| EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM (K131802) | Depuy Spine, A Johnson & Johnson Company | 2013-09-12 |
| POLARIS SPINAL SYSTEM (K131615) | Biomet Spine (Aka Ebi, LLC) | 2013-09-04 |
| RANGE SPINAL SYSTEM (K131784) | K2m, Inc. | 2013-08-30 |
| CD HORIZON SPINAL SYSTEM (K131321) | Medtronic Sofamor Danek USA | 2013-06-05 |
| CREO STABILIZATION SYSTEM (K124058) | Globus Medical, Inc. | 2013-05-13 |
| RANGE SPINAL SYSTEM (K131030) | K2m, Inc. | 2013-05-09 |
| RESPONSE SPINE SYSTEM (K130655) | OrthoPediatrics Corp. | 2013-05-08 |
| RANGE SPINAL SYSTEM, SMALL STATURE (K122877) | K2m, Inc. | 2013-05-08 |
Recalls involving this device
No recalls on record reference this clearance.