The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Osteostim Granules-resorbable Bone Graft Substitute.
| Device ID | K011386 |
| 510k Number | K011386 |
| Device Name: | EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Jon Caparotta |
| Correspondent | Jon Caparotta EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-07 |
| Decision Date | 2001-08-03 |