K992570 is an FDA 510(k) clearance for the UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II - Special Controls, product code KWL).
Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on September 1, 1999, 30 days after receiving the submission on August 2, 1999.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K992570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1999 |
| Decision Date | September 01, 1999 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWL — Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |