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