The following data is part of a premarket notification filed by Biomet Spine (aka Ebi, Llc) with the FDA for Biomet Access System.
| Device ID | K132373 |
| 510k Number | K132373 |
| Device Name: | BIOMET ACCESS SYSTEM |
| Classification | Neurosurgical Nerve Locator |
| Applicant | BIOMET SPINE (AKA EBI, LLC) 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Vivian Kelly, Ms, Rac |
| Correspondent | Vivian Kelly, Ms, Rac BIOMET SPINE (AKA EBI, LLC) 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | PDQ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-30 |
| Decision Date | 2014-03-27 |
| Summary: | summary |