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FDA 510(k)

Spacer-G and Spacer-K

K-Number: K101356 · 2011-09-20

ApplicantTecres S.P.A.
Decision Date2011-09-20
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spacer-G and Spacer-K is the device name listed in this FDA 510(k) record. The listed applicant is Tecres S.P.A.. It received FDA 510(k) clearance on 2011-09-20 under 510(k) number K101356. 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 Spacer-G and Spacer-K?

Spacer-G and Spacer-K is a medical device that received FDA 510(k) clearance on 2011-09-20. The listed applicant is Tecres S.P.A.. The 510(k) number is K101356.

When did Spacer-G and Spacer-K receive FDA 510(k) clearance?

Spacer-G and Spacer-K received FDA 510(k) clearance on 2011-09-20, under 510(k) number K101356.

Who is the listed applicant for Spacer-G and Spacer-K?

The FDA 510(k) record lists Tecres S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spacer-G and Spacer-K?

The FDA product code for Spacer-G and Spacer-K is KWL.

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Other records listing Tecres S.P.A. 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.

K252326InterSpace GV Hip SpacerK211163Bone Cement Genta, Bone Cement HV, Bone Cement LVK220131KYPHON VuE Bone CementK181732InterSpace Knee Extra-Large Size, InterSpace Knee ATSK122175MENDEC SPINE HV, MENDEC SPINE HV SYSTEMK112983SPACER-S

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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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