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FDA 510(k)

Optimized Positioning System (OPS) ReView

K-Number: K193042 · 2020-06-26

ApplicantCorin USA
Decision Date2020-06-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Optimized Positioning System (OPS) ReView is a medical device manufactured by Corin USA. It received FDA 510(k) clearance on 2020-06-26 under approval number K193042. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optimized Positioning System (OPS) ReView?

Optimized Positioning System (OPS) ReView is a medical device that received FDA 510(k) clearance on 2020-06-26. It is manufactured by Corin USA. The 510(k) number is K193042.

When was Optimized Positioning System (OPS) ReView approved by the FDA?

Optimized Positioning System (OPS) ReView received FDA 510(k) clearance on 2020-06-26, under approval number K193042.

What company makes Optimized Positioning System (OPS) ReView?

Optimized Positioning System (OPS) ReView is manufactured by Corin USA.

What is the FDA product code for Optimized Positioning System (OPS) ReView?

The FDA product code for Optimized Positioning System (OPS) ReView is LLZ.

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Related PubMed Literature

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Other Devices by Corin USA

K152893Corin Optimized Positioning System (OPS) K152903REVIVAL(TM) Modular Revision Hip Stem K183038Corin Optimized Positioning System (OPS) Plan K181061Corin Optimized Positioning System (OPS) Femoral K190143LARS AC Band Device K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)

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Related Devices (Code: LLZ)

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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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