The following data is part of a premarket notification filed by Regeneration Technologies, Inc. with the FDA for Regenafil, Regenaform, Alriva Dbm Paste, Sltiva Dm With Cortical Cancellous Ships, Bioset, Sioset Ic, Rti Allograft Past.
| Device ID | K080418 |
| 510k Number | K080418 |
| Device Name: | REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST |
| Classification | Bone Grafting Material, Human Source |
| Applicant | REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 Alachua, FL 32616 -2650 |
| Contact | Travis Arola |
| Correspondent | Travis Arola REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 Alachua, FL 32616 -2650 |
| Product Code | NUN |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-02-15 |
| Decision Date | 2008-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854095006801 | K080418 | 000 |
| 00191083045085 | K080418 | 000 |
| 00191083045115 | K080418 | 000 |
| 00854095006740 | K080418 | 000 |
| 00854095006757 | K080418 | 000 |
| 00854095006764 | K080418 | 000 |
| 00854095006771 | K080418 | 000 |
| 00854095006788 | K080418 | 000 |
| 00854095006795 | K080418 | 000 |
| 00191083045078 | K080418 | 000 |