K952534 is an FDA 510(k) clearance for the TENTATIVELY POLARUS EX ROD. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Acu Med, Inc. (Beaveton, US). The FDA issued a Cleared decision on July 13, 1995, 42 days after receiving the submission on June 1, 1995.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K952534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1995 |
| Decision Date | July 13, 1995 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HSB — Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |