The following data is part of a premarket notification filed by Regeneration Technologies, Inc. with the FDA for Sterling Cancellous Chips; Sterling Cancellous Cubes.
| Device ID | K051615 |
| 510k Number | K051615 |
| Device Name: | STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES |
| 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 | 2005-06-17 |
| Decision Date | 2005-08-15 |
| Summary: | summary |