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FDA 510(k)

Corin Optimized Position System Functional Hip Analysis (OPS FHA)

K-Number: K190834 · 2019-07-22

ApplicantCorin USA
Decision Date2019-07-22
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Corin Optimized Position System Functional Hip Analysis (OPS FHA) is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2019-07-22 under 510(k) number K190834. 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 Position System Functional Hip Analysis (OPS FHA)?

Corin Optimized Position System Functional Hip Analysis (OPS FHA) is a medical device that received FDA 510(k) clearance on 2019-07-22. The listed applicant is Corin USA. The 510(k) number is K190834.

When did Corin Optimized Position System Functional Hip Analysis (OPS FHA) receive FDA 510(k) clearance?

Corin Optimized Position System Functional Hip Analysis (OPS FHA) received FDA 510(k) clearance on 2019-07-22, under 510(k) number K190834.

Who is the listed applicant for Corin Optimized Position System Functional Hip Analysis (OPS FHA)?

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 Position System Functional Hip Analysis (OPS FHA)?

The FDA product code for Corin Optimized Position System Functional Hip Analysis (OPS FHA) 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.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.

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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