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FDA 510(k)

OMNICUT RESECTION BLADE

K-Number: K130912 · 2013-06-14

ApplicantDepuy Mitek, A Johnson & Johnson Company
Decision Date2013-06-14
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMNICUT RESECTION BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. It received FDA 510(k) clearance on 2013-06-14 under 510(k) number K130912. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNICUT RESECTION BLADE?

OMNICUT RESECTION BLADE is a medical device that received FDA 510(k) clearance on 2013-06-14. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. The 510(k) number is K130912.

When did OMNICUT RESECTION BLADE receive FDA 510(k) clearance?

OMNICUT RESECTION BLADE received FDA 510(k) clearance on 2013-06-14, under 510(k) number K130912.

Who is the listed applicant for OMNICUT RESECTION BLADE?

The FDA 510(k) record lists Depuy Mitek, A Johnson & Johnson Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNICUT RESECTION BLADE?

The FDA product code for OMNICUT RESECTION BLADE is HRX.

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Other records listing Depuy Mitek, A Johnson & Johnson Company as applicant

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Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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