The following data is part of a premarket notification filed by Biomet Spine with the FDA for Peek-optima Alif Spacer.
| Device ID | K081636 |
| 510k Number | K081636 |
| Device Name: | PEEK-OPTIMA ALIF SPACER |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | BIOMET SPINE 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly BIOMET SPINE 100 INTERPACE PARKWAY 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 | 2008-06-11 |
| Decision Date | 2008-08-07 |
| Summary: | summary |