The following data is part of a premarket notification filed by Calcitec, Inc with the FDA for Osteofix Bone Void Filler.
| Device ID | K070220 |
| 510k Number | K070220 |
| Device Name: | OSTEOFIX BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | CALCITEC, INC 1835 MARKET STREET, 28TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan CALCITEC, INC 1835 MARKET STREET, 28TH FLOOR Philadelphia, PA 19103 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-23 |
| Decision Date | 2007-04-12 |
| Summary: | summary |