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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 a medical device manufactured by Biomet Microfixation. It received FDA 510(k) clearance on 2019-06-05 under approval 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. It is manufactured by Biomet Microfixation. The 510(k) number is K190576.

When was WalterLorenz Surgical Assist Arm Scope Holder approved by the FDA?

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

What company makes WalterLorenz Surgical Assist Arm Scope Holder?

WalterLorenz Surgical Assist Arm Scope Holder is manufactured by Biomet Microfixation.

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.

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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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