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FDA 510(k)

OsteoRemedies Hip Spacer System

K-Number: K192995 · 2020-01-10

ApplicantOsteoremedies, LLC
Decision Date2020-01-10
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoRemedies Hip Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Osteoremedies, LLC. It received FDA 510(k) clearance on 2020-01-10 under 510(k) number K192995. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoRemedies Hip Spacer System?

OsteoRemedies Hip Spacer System is a medical device that received FDA 510(k) clearance on 2020-01-10. The listed applicant is Osteoremedies, LLC. The 510(k) number is K192995.

When did OsteoRemedies Hip Spacer System receive FDA 510(k) clearance?

OsteoRemedies Hip Spacer System received FDA 510(k) clearance on 2020-01-10, under 510(k) number K192995.

Who is the listed applicant for OsteoRemedies Hip Spacer System?

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

What is the FDA product code for OsteoRemedies Hip Spacer System?

The FDA product code for OsteoRemedies Hip Spacer System is KWL.

Other records listing Osteoremedies, LLC 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.

K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupK253675OsteoRemedies Hip Spacer SystemK250760SPECTRUM GV Bone CementK242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentK231556SPECTRUM® GV Bone CementK223650REMEDY Stemmed Knee Spacer

View all 11 devices →

Related Devices (Code: KWL)

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.

K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLCK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UCK253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLCK252326InterSpace GV Hip SpacerTecres S.P.A.K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd.K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbH

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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