K071437 is an FDA 510(k) clearance for the MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on September 12, 2007, 112 days after receiving the submission on May 23, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K071437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2007 |
| Decision Date | September 12, 2007 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| 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 |