SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
FDA 510(k) clearance K131548 · decided 2014-02-28
Clearance details
- K-number
- K131548
- Device name
- SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
- Applicant
- Synthes (USA) Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-05-30
- Decision date
- 2014-02-28
- Days to decision
- 274 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Synthes (USA) Products
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.