The following data is part of a premarket notification filed by Regeneration Technologies, Inc. with the FDA for Osteofil, Optefil, Regenafil, Rti Allograft Paste.
| Device ID | K043420 |
| 510k Number | K043420 |
| Device Name: | OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 Alachua, FL 32616 -2650 |
| Contact | Carrie Hartill |
| Correspondent | Carrie Hartill REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 Alachua, FL 32616 -2650 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-13 |
| Decision Date | 2005-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854095006979 | K043420 | 000 |
| 00854095006283 | K043420 | 000 |
| 00854095006276 | K043420 | 000 |
| 00898623002125 | K043420 | 000 |
| 00898623002118 | K043420 | 000 |
| 00898623002101 | K043420 | 000 |
| 00898623002026 | K043420 | 000 |
| 00898623002019 | K043420 | 000 |
| 00898623002002 | K043420 | 000 |
| 10885862094667 | K043420 | 000 |
| 10885862094650 | K043420 | 000 |
| 10885862094643 | K043420 | 000 |
| 10885862094407 | K043420 | 000 |
| 10885862094391 | K043420 | 000 |
| 00854095006290 | K043420 | 000 |
| 00854095006306 | K043420 | 000 |
| 00854095006313 | K043420 | 000 |
| 00854095006962 | K043420 | 000 |
| 00854095006955 | K043420 | 000 |
| 00854095006849 | K043420 | 000 |
| 00854095006832 | K043420 | 000 |
| 00854095006825 | K043420 | 000 |
| 00854095006818 | K043420 | 000 |
| 00854095006634 | K043420 | 000 |
| 00854095006627 | K043420 | 000 |
| 00854095006610 | K043420 | 000 |
| 00854095006603 | K043420 | 000 |
| 00854095006344 | K043420 | 000 |
| 00854095006337 | K043420 | 000 |
| 00854095006320 | K043420 | 000 |
| 10885862094384 | K043420 | 000 |