ATEC Universal Spacer System
FDA 510(k) clearance K180480 · decided 2018-05-31
Clearance details
- K-number
- K180480
- Device name
- ATEC Universal Spacer System
- Applicant
- Alphatec Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-02-23
- Decision date
- 2018-05-31
- Days to decision
- 97 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 |
|---|---|---|
| Battalion Universal Spacer System (K160958) | Alphatec Spine | 2016-09-08 |
| NuVasive CoRoent Thoracolumbar Implants (K150994) | Nu Vasive, Incorporated | 2015-06-17 |
Recalls involving this device
No recalls on record reference this clearance.