The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Expandable Peek-optima Implant.
| Device ID | K082406 |
| 510k Number | K082406 |
| Device Name: | EXPANDABLE PEEK-OPTIMA IMPLANT |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-21 |
| Decision Date | 2009-01-14 |
| Summary: | summary |