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FDA 510(k)

Attune Revision LPS Inserts

K-Number: K191779 · 2019-10-08

ApplicantDepuy(Ireland)
Decision Date2019-10-08
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Attune Revision LPS Inserts is the device name listed in this FDA 510(k) record. The listed applicant is Depuy(Ireland). It received FDA 510(k) clearance on 2019-10-08 under 510(k) number K191779. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Attune Revision LPS Inserts?

Attune Revision LPS Inserts is a medical device that received FDA 510(k) clearance on 2019-10-08. The listed applicant is Depuy(Ireland). The 510(k) number is K191779.

When did Attune Revision LPS Inserts receive FDA 510(k) clearance?

Attune Revision LPS Inserts received FDA 510(k) clearance on 2019-10-08, under 510(k) number K191779.

Who is the listed applicant for Attune Revision LPS Inserts?

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

What is the FDA product code for Attune Revision LPS Inserts?

The FDA product code for Attune Revision LPS Inserts is KRO.

Other records listing Depuy(Ireland) 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.

K212683GLOBAL ICON Stemless Shoulder SystemK192855DELTA XTEND(TM) Reverse Shoulder SystemK190344DePuy Corail AMT Hip ProsthesisK192448Delta Xtend Revers Shoulder SystemK183077Delta Xtend Reverse Shoulder SystemK170806ATTUNE Cemented Tibial Base, Fixed Bearing

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Related Devices (Code: KRO)

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.

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker OrthopaedicsK252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK252303Stem Extension Line (USTAR II System)United Orthopedic CorporationK251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK242871ATTUNE™ Revision Hinge KneeDepuy Ireland UCK240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseMicroport 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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