CorticaLINK Spinal Fusion Platform
FDA 510(k) clearance K160722 · decided 2016-07-07
Clearance details
- K-number
- K160722
- Device name
- CorticaLINK Spinal Fusion Platform
- Applicant
- Facetlink Dba Linkspine
- Decision
- Substantially Equivalent
- Date received
- 2016-03-16
- Decision date
- 2016-07-07
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rockaway, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Facetlink Dba Linkspine
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.
Recalls involving this device
No recalls on record reference this clearance.