The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Resorbable Room Temperature Bone Paste.
| Device ID | K040755 |
| 510k Number | K040755 |
| Device Name: | EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Rebecca Roberts |
| Correspondent | Rebecca Roberts EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-24 |
| Decision Date | 2004-06-17 |
| Summary: | summary |