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FDA 510(k)

BLACK WIDOW ANTERIOR BUTTRESS PLATE

K-Number: K081770 · 2009-04-02

ApplicantOmni Surgical, L.P.
Decision Date2009-04-02
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BLACK WIDOW ANTERIOR BUTTRESS PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Omni Surgical, L.P.. It received FDA 510(k) clearance on 2009-04-02 under 510(k) number K081770. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLACK WIDOW ANTERIOR BUTTRESS PLATE?

BLACK WIDOW ANTERIOR BUTTRESS PLATE is a medical device that received FDA 510(k) clearance on 2009-04-02. The listed applicant is Omni Surgical, L.P.. The 510(k) number is K081770.

When did BLACK WIDOW ANTERIOR BUTTRESS PLATE receive FDA 510(k) clearance?

BLACK WIDOW ANTERIOR BUTTRESS PLATE received FDA 510(k) clearance on 2009-04-02, under 510(k) number K081770.

Who is the listed applicant for BLACK WIDOW ANTERIOR BUTTRESS PLATE?

The FDA 510(k) record lists Omni Surgical, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLACK WIDOW ANTERIOR BUTTRESS PLATE?

The FDA product code for BLACK WIDOW ANTERIOR BUTTRESS PLATE is KWQ.

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Other records listing Omni Surgical, L.P. as applicant

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Related Devices (Code: KWQ)

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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