PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS
FDA 510(k) clearance K071174 · decided 2007-07-25
Clearance details
- K-number
- K071174
- Device name
- PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS
- Applicant
- Abbott Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-27
- Decision date
- 2007-07-25
- Days to decision
- 89 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott Spine
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.