K904180 is an FDA 510(k) clearance for the PROSTHETIC CEMENT REMOVER. This device is classified as a System, Cement Removal Extraction (Class II — Special Controls, product code LZV).
Submitted by Origin Medsystems, Inc. (San Mateo, US). The FDA issued a Cleared decision on November 20, 1990, 70 days after receiving the submission on September 11, 1990.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4580.
| 510(k) Number | K904180 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1990 |
| Decision Date | November 20, 1990 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LZV — System, Cement Removal Extraction |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.4580 |