The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Vertebroplasty Systems.
| Device ID | K060148 |
| 510k Number | K060148 |
| Device Name: | EBI VERTEBROPLASTY SYSTEMS |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-19 |
| Decision Date | 2006-03-13 |
| Summary: | summary |