The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Stimulan- Calcium Sulfate Bone Void Filler.
| Device ID | K982663 |
| 510k Number | K982663 |
| Device Name: | STIMULAN- CALCIUM SULFATE BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Debbie De Los Santos |
| Correspondent | Debbie De Los Santos ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-30 |
| Decision Date | 1999-02-26 |
| Summary: | summary |