K002484 is an FDA 510(k) clearance for the EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL. This device is classified as a Instrument, Surgical, Sonic And Accessory/attachment (Class II - Special Controls, product code JDX).
Submitted by Electro Medical Systems SA (North Attleboro, US). The FDA issued a Cleared decision on October 4, 2000, 51 days after receiving the submission on August 14, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4580.
| 510(k) Number | K002484 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2000 |
| Decision Date | October 04, 2000 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDX — Instrument, Surgical, Sonic And Accessory/attachment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.4580 |