K010545 is an FDA 510(k) clearance for the TBW. This device is classified as a Pin, Fixation, Smooth, Metallic (Class II - Special Controls, product code NDL).
Submitted by Tri-Med, Inc. (Kailua,, US). The FDA issued a Cleared decision on June 6, 2001, 103 days after receiving the submission on February 23, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K010545 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2001 |
| Decision Date | June 06, 2001 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NDL — Pin, Fixation, Smooth, Metallic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |