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FDA 510(k)

Responsive Orthopedics Total Hip Arthroplasty System

K-Number: K163585 · 2017-06-02

ApplicantResponsive Orthopedics, LLC
Decision Date2017-06-02
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Responsive Orthopedics Total Hip Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Responsive Orthopedics, LLC. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K163585. 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 Responsive Orthopedics Total Hip Arthroplasty System?

Responsive Orthopedics Total Hip Arthroplasty System is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Responsive Orthopedics, LLC. The 510(k) number is K163585.

When did Responsive Orthopedics Total Hip Arthroplasty System receive FDA 510(k) clearance?

Responsive Orthopedics Total Hip Arthroplasty System received FDA 510(k) clearance on 2017-06-02, under 510(k) number K163585.

Who is the listed applicant for Responsive Orthopedics Total Hip Arthroplasty System?

The FDA 510(k) record lists Responsive Orthopedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Responsive Orthopedics Total Hip Arthroplasty System?

The FDA product code for Responsive Orthopedics Total Hip Arthroplasty System is LZO.

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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