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FDA 510(k)

GENflex2 Total Knee System

K-Number: K162222 · 2016-09-07

ApplicantStelkast, Inc.
Decision Date2016-09-07
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GENflex2 Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast, Inc.. It received FDA 510(k) clearance on 2016-09-07 under 510(k) number K162222. 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 GENflex2 Total Knee System?

GENflex2 Total Knee System is a medical device that received FDA 510(k) clearance on 2016-09-07. The listed applicant is Stelkast, Inc.. The 510(k) number is K162222.

When did GENflex2 Total Knee System receive FDA 510(k) clearance?

GENflex2 Total Knee System received FDA 510(k) clearance on 2016-09-07, under 510(k) number K162222.

Who is the listed applicant for GENflex2 Total Knee System?

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

What is the FDA product code for GENflex2 Total Knee System?

The FDA product code for GENflex2 Total Knee System is JWH.

Other records listing Stelkast, Inc. 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.

K190276Provident II Hip StemK173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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