CREO STABILIZATION SYSTEM
FDA 510(k) clearance K124058 · decided 2013-05-13
Clearance details
- K-number
- K124058
- Device name
- CREO STABILIZATION SYSTEM
- Applicant
- Globus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-31
- Decision date
- 2013-05-13
- 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
- Audubon, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Globus Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OLYMPIC Posterior Spinal Fixation System (K153446) | Astura Medical | 2016-04-08 |
| 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 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SECURE®-C Cervical Artificial Disc (P100003/S008) | Globus Medical, Inc. | 2023-06-12 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S007) | Globus Medical, Inc. | 2017-08-18 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S006) | Globus Medical, Inc. | 2016-05-17 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S005) | Globus Medical, Inc. | 2014-12-18 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S004) | Globus Medical, Inc. | 2014-06-30 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S003) | Globus Medical, Inc. | 2014-05-08 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S002) | Globus Medical, Inc. | 2013-09-06 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S001) | Globus Medical, Inc. | 2013-03-15 |