LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
FDA 510(k) clearance K103040 · decided 2011-02-08
Clearance details
- K-number
- K103040
- Device name
- LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
- Applicant
- Lanx, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-10-13
- Decision date
- 2011-02-08
- Days to decision
- 118 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Broomfield, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Lanx
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.