The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Esl Peek-optima Spine System.
| Device ID | K061016 |
| 510k Number | K061016 |
| Device Name: | EBI ESL PEEK-OPTIMA SPINE SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Jennifer Harakal |
| Correspondent | Jennifer Harakal EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-13 |
| Decision Date | 2006-06-08 |
| Summary: | summary |