The following data is part of a premarket notification filed by Scient'x with the FDA for Biofill Bone Void Filler.
| Device ID | K040454 |
| 510k Number | K040454 |
| Device Name: | BIOFILL BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SCIENT'X 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb SCIENT'X 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-23 |
| Decision Date | 2004-05-07 |
| Summary: | summary |