Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Corin Optimized Positioning System (OPS) Femoral

K-Number: K181061 · 2018-09-07

ApplicantCorin USA
Decision Date2018-09-07
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Corin Optimized Positioning System (OPS) Femoral is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K181061. 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) Femoral?

Corin Optimized Positioning System (OPS) Femoral is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Corin USA. The 510(k) number is K181061.

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

Corin Optimized Positioning System (OPS) Femoral received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181061.

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

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) Femoral?

The FDA product code for Corin Optimized Positioning System (OPS) Femoral 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

View all 12 devices →

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.

↑