K930629 is an FDA 510(k) clearance for the ACRYL-X II SYSTEM. This device is classified as a System, Cement Removal Extraction (Class II - Special Controls, product code LZV).
Submitted by Sonokinetics, Inc. (Hoboken, US). The FDA issued a Cleared decision on January 21, 1994, 347 days after receiving the submission on February 8, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4580.
| 510(k) Number | K930629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 1993 |
| Decision Date | January 21, 1994 |
| Days to Decision | 347 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LZV — System, Cement Removal Extraction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.4580 |