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FDA 510(k)

Unity Total Knee System

K-Number: K170808 · 2017-07-13

ApplicantCorin U.S.A. Limited
Decision Date2017-07-13
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Unity Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Corin U.S.A. Limited. It received FDA 510(k) clearance on 2017-07-13 under 510(k) number K170808. 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 Unity Total Knee System?

Unity Total Knee System is a medical device that received FDA 510(k) clearance on 2017-07-13. The listed applicant is Corin U.S.A. Limited. The 510(k) number is K170808.

When did Unity Total Knee System receive FDA 510(k) clearance?

Unity Total Knee System received FDA 510(k) clearance on 2017-07-13, under 510(k) number K170808.

Who is the listed applicant for Unity Total Knee System?

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

What is the FDA product code for Unity Total Knee System?

The FDA product code for Unity Total Knee System is JWH.

Other records listing Corin U.S.A. Limited 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.

K242744Trinity EVO Acetabular ShellK241808ApolloHipX (THR.SS.0001)K241472Icona Hip StemK241570Unity Total Knee SystemK240875Unity Knee PS-C Tibial InsertK231172ApolloKnee

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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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