K000321 is an FDA 510(k) clearance for the HEMISPHERE MODULAR CUP SYSTEM. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II - Special Controls, product code LPH).
Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on April 10, 2000, 68 days after receiving the submission on February 2, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K000321 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2000 |
| Decision Date | April 10, 2000 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3358 |