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FDA 510(k)

Corin Optimized Positioning System (OPS)

K-Number: K152893 · 2016-06-03

ApplicantCorin USA
Decision Date2016-06-03
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Corin Optimized Positioning System (OPS) is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K152893. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Corin Optimized Positioning System (OPS)?

Corin Optimized Positioning System (OPS) is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Corin USA. The 510(k) number is K152893.

When did Corin Optimized Positioning System (OPS) receive FDA 510(k) clearance?

Corin Optimized Positioning System (OPS) received FDA 510(k) clearance on 2016-06-03, under 510(k) number K152893.

Who is the listed applicant for Corin Optimized Positioning System (OPS)?

The FDA 510(k) record lists Corin USA as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Corin Optimized Positioning System (OPS) is LZO.

Other records listing Corin USA as applicant

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.

K203751OMNIVision systemK202805Optimized Positioning System (OPS) InsightK193545Corin Optimized Positioning System (OPS) FemoralPMA P050016Prosthesis, hip, semi-constrained, metal/metal, resurfacingK193042Optimized Positioning System (OPS) ReViewK192656Optimized Positioning System (OPS) Insight

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Related Devices (Code: LZO)

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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