K953194 is an FDA 510(k) clearance for the LACTOSORB BONE PIN. This device is classified as a Pin, Fixation, Smooth (Class II - Special Controls, product code HTY).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 31, 1995, 113 days after receiving the submission on July 10, 1995.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K953194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | July 10, 1995 |
| Decision Date | October 31, 1995 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HTY — Pin, Fixation, Smooth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |