BIOMET ACCESS SYSTEM— 510(k) K132373

Substantially Equivalent

Biomet Spine (Aka Ebi, LLC)

FDA 510(k) clearance K132373 for BIOMET ACCESS SYSTEM, Substantially Equivalent on 2014-03-27. Applicant: Biomet Spine (Aka Ebi, LLC). Device class: 2.

Clearance details

Applicant
Biomet Spine (Aka Ebi, LLC)
Product code
Code PDQ
Device class
Class 2
Regulation
21 CFR 874.1820
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Parsippany, NJ, US
Download summary PDFView on FDA.gov ↗

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