Biomet Access System
FDA 510(k) K132373 · Biomet Spine (Aka Ebi, LLC)
510(k) numberK132373
Submission
- Device name
- Biomet Access System
- Applicant
- Biomet Spine (Aka Ebi, LLC)
Parsippany, NJ, US - Received
- July 30, 2013
- Decision date
- March 27, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDQ – Neurosurgical Nerve Locator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1820
- Specialty
- Ear, Nose, Throat
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
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| K133746 | Polaris Spinal SystemNKB · Traditional | 03/12/2014SE |
| K131615 | Polaris Spinal SystemOSH · Traditional | 09/04/2013SE |
| K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemNKB · Traditional | 02/25/2013SE |
| K123451 | Polaris Spinal System - Ballista II RodsNKB · Special | 12/03/2012SE |
| K122989 | Biomet Lateral Spacer SystemMAX · Traditional | 10/24/2012SE |
| K122378 | Nextgen Altius Oct SystemKWP · Special | 09/20/2012SE |
| K113593 | Nextgen Altius Oct SystemKWP · Traditional | 04/17/2012SE |
| K110650 | Zyston Arc Interbody SpacerMAX · Traditional | 06/30/2011SE |
Questions and answers
When was Biomet Access System cleared by the FDA?
Biomet Access System (K132373) received a 510(k) decision of Substantially Equivalent on March 27, 2014, 240 days after the submission was received.
What is the product code of K132373?
The FDA product code is PDQ – Neurosurgical Nerve Locator, a Class II (moderate risk) device regulated under 21 CFR 874.1820.