The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Biomet Anterior Lumbar Plate.
| Device ID | K082187 |
| 510k Number | K082187 |
| Device Name: | BIOMET ANTERIOR LUMBAR PLATE |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Vivian Kelly Ms, Rac |
| Correspondent | Vivian Kelly Ms, Rac EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-04 |
| Decision Date | 2008-11-13 |
| Summary: | summary |