The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Cross.bone.
| Device ID | K071876 |
| 510k Number | K071876 |
| Device Name: | CROSS.BONE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | TRIMED, INC. 25864 TOURNAMENT RD. SUITE A Valencia, CA 91355 |
| Contact | Kelli Anderson |
| Correspondent | Kelli Anderson TRIMED, INC. 25864 TOURNAMENT RD. SUITE A Valencia, CA 91355 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-06 |
| Decision Date | 2007-12-17 |
| Summary: | summary |