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FDA 510(k)

BIOMET MICROFIXATION NEURO PLATING SYSTEM

K-Number: K121624 · 2012-10-12

ApplicantBiomet Microfixation
Decision Date2012-10-12
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOMET MICROFIXATION NEURO PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2012-10-12 under 510(k) number K121624. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMET MICROFIXATION NEURO PLATING SYSTEM?

BIOMET MICROFIXATION NEURO PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-10-12. The listed applicant is Biomet Microfixation. The 510(k) number is K121624.

When did BIOMET MICROFIXATION NEURO PLATING SYSTEM receive FDA 510(k) clearance?

BIOMET MICROFIXATION NEURO PLATING SYSTEM received FDA 510(k) clearance on 2012-10-12, under 510(k) number K121624.

Who is the listed applicant for BIOMET MICROFIXATION NEURO PLATING SYSTEM?

The FDA 510(k) record lists Biomet Microfixation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOMET MICROFIXATION NEURO PLATING SYSTEM?

The FDA product code for BIOMET MICROFIXATION NEURO PLATING SYSTEM is GWO.

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Related Devices (Code: GWO)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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