K001724 is an FDA 510(k) clearance for the STIMULAN -CALCIUM SULFATE BONE VOID FILTER. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).
Submitted by Biocomposites, Ltd. (Stoke On Trent, GB). The FDA issued a Cleared decision on August 4, 2000, 59 days after receiving the submission on June 6, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K001724 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2000 |
| Decision Date | August 04, 2000 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MQV — Filler, Bone Void, Calcium Compound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3045 |