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FDA 510(k)

World Knee Total Knee Systems

K-Number: K190577 · 2019-11-27

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2019-11-27
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

World Knee Total Knee Systems is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2019-11-27 under 510(k) number K190577. 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 World Knee Total Knee Systems?

World Knee Total Knee Systems is a medical device that received FDA 510(k) clearance on 2019-11-27. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K190577.

When did World Knee Total Knee Systems receive FDA 510(k) clearance?

World Knee Total Knee Systems received FDA 510(k) clearance on 2019-11-27, under 510(k) number K190577.

Who is the listed applicant for World Knee Total Knee Systems?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for World Knee Total Knee Systems?

The FDA product code for World Knee Total Knee Systems is JWH.

Other records listing Signature Orthopaedics Pty, Ltd. 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.

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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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