K050101 is an FDA 510(k) clearance for the THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10. This device is classified as a Plate, Fixation, Bone (Class II — Special Controls, product code HRS).
Submitted by Zimmer Trabecular (Allendale, US). The FDA issued a Cleared decision on April 15, 2005, 87 days after receiving the submission on January 18, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K050101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2005 |
| Decision Date | April 15, 2005 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3030 |