BIOMET ACCESS SYSTEM
FDA 510(k) clearance K132373 · decided 2014-03-27
Clearance details
- K-number
- K132373
- Device name
- BIOMET ACCESS SYSTEM
- Applicant
- Biomet Spine (Aka Ebi, LLC)
- Decision
- Substantially Equivalent
- Date received
- 2013-07-30
- Decision date
- 2014-03-27
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- PDQ
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.