The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Pro Osteon 500r.
| Device ID | K063346 |
| 510k Number | K063346 |
| Device Name: | PRO OSTEON 500R |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Debra Bing |
| Correspondent | Debra Bing 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 | 2006-11-03 |
| Decision Date | 2007-04-18 |
| Summary: | summary |