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FDA 510(k)

ATTUNE Cemented Tibial Base, Fixed Bearing

K-Number: K170806 · 2017-06-15

ApplicantDepuy(Ireland)
Decision Date2017-06-15
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATTUNE Cemented Tibial Base, Fixed Bearing is the device name listed in this FDA 510(k) record. The listed applicant is Depuy(Ireland). It received FDA 510(k) clearance on 2017-06-15 under 510(k) number K170806. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATTUNE Cemented Tibial Base, Fixed Bearing?

ATTUNE Cemented Tibial Base, Fixed Bearing is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Depuy(Ireland). The 510(k) number is K170806.

When did ATTUNE Cemented Tibial Base, Fixed Bearing receive FDA 510(k) clearance?

ATTUNE Cemented Tibial Base, Fixed Bearing received FDA 510(k) clearance on 2017-06-15, under 510(k) number K170806.

Who is the listed applicant for ATTUNE Cemented Tibial Base, Fixed Bearing?

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 Cemented Tibial Base, Fixed Bearing?

The FDA product code for ATTUNE Cemented Tibial Base, Fixed Bearing is JWH.

Related Clinical Trials

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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 ProsthesisK191779Attune Revision LPS InsertsK192448Delta Xtend Revers Shoulder SystemK183077Delta Xtend Reverse Shoulder System

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Related Devices (Code: JWH)

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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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