K080101 is an FDA 510(k) clearance for the AAP CANNULATED SCREW AND DARCO HEADED SCREW. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Aap Implantate AG (Berlin, DE). The FDA issued a Cleared decision on March 25, 2008, 71 days after receiving the submission on January 14, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K080101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 2008 |
| Decision Date | March 25, 2008 |
| Days to Decision | 71 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |