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FDA 510(k)

WalterLorenz Surgical Assist Arm Scope Holder

K-Number: K190576 · 2019-06-05

ApplicantBiomet Microfixation
Decision Date2019-06-05
Product CodeOCV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WalterLorenz Surgical Assist Arm Scope Holder is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2019-06-05 under 510(k) number K190576. The device is classified under product code OCV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WalterLorenz Surgical Assist Arm Scope Holder?

WalterLorenz Surgical Assist Arm Scope Holder is a medical device that received FDA 510(k) clearance on 2019-06-05. The listed applicant is Biomet Microfixation. The 510(k) number is K190576.

When did WalterLorenz Surgical Assist Arm Scope Holder receive FDA 510(k) clearance?

WalterLorenz Surgical Assist Arm Scope Holder received FDA 510(k) clearance on 2019-06-05, under 510(k) number K190576.

Who is the listed applicant for WalterLorenz Surgical Assist Arm Scope Holder?

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 WalterLorenz Surgical Assist Arm Scope Holder?

The FDA product code for WalterLorenz Surgical Assist Arm Scope Holder is OCV.

Other records listing Biomet Microfixation as applicant

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Related Devices (Code: OCV)

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.

K240506KARL STORZ HoldersKarl Storz Endoscopy America, Inc.K232405ENDOFIX EXOAktormed GmbH

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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