The following data is part of a premarket notification filed by Teknimed Sa with the FDA for Ceraform Bone Void Filler.
| Device ID | K040669 |
| 510k Number | K040669 |
| Device Name: | CERAFORM BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | TEKNIMED SA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb TEKNIMED SA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-15 |
| Decision Date | 2004-05-03 |
| Summary: | summary |