K993004 is an FDA 510(k) clearance for the ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW. This device is classified as a Nail, Fixation, Bone (Class II - Special Controls, product code JDS).
Submitted by Howmedica Osteonics Corp. (Rutherford, US). The FDA issued a Cleared decision on October 6, 1999, 29 days after receiving the submission on September 7, 1999.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K993004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 1999 |
| Decision Date | October 06, 1999 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDS — Nail, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |