NuVasive CoRoent Thoracolumbar Implants
FDA 510(k) clearance K150994 · decided 2015-06-17
Clearance details
- K-number
- K150994
- Device name
- NuVasive CoRoent Thoracolumbar Implants
- Applicant
- Nu Vasive, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2015-04-15
- Decision date
- 2015-06-17
- Days to decision
- 63 days
- Clearance type
- Special
- Product code
- PHM
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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| ATEC Universal Spacer System (K180480) | Alphatec Spine, Inc. | 2018-05-31 |
| Battalion Universal Spacer System (K160958) | Alphatec Spine | 2016-09-08 |
Recalls involving this device
No recalls on record reference this clearance.