ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
FDA 510(k) clearance K091566 · decided 2009-10-28
Clearance details
- K-number
- K091566
- Device name
- ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
- Applicant
- Zimmer GmbH
- Decision
- Substantially Equivalent
- Date received
- 2009-05-28
- Decision date
- 2009-10-28
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zimmer GmbH
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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
| Record | Firm | Date |
|---|---|---|
| Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System i recall (Z-0119-2016) | Zimmer Gmbh | 2015-10-14 |
| Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long, Catalog 00-2490-003-5 recall (Z-0824-2011) | Zimmer Inc. | 2010-12-28 |