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FDA 510(k)

SurgTech GENOLL Total Knee System

K-Number: K191192 · 2019-08-01

ApplicantSurgtech, Inc.
Decision Date2019-08-01
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SurgTech GENOLL Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Surgtech, Inc.. It received FDA 510(k) clearance on 2019-08-01 under 510(k) number K191192. 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 SurgTech GENOLL Total Knee System?

SurgTech GENOLL Total Knee System is a medical device that received FDA 510(k) clearance on 2019-08-01. The listed applicant is Surgtech, Inc.. The 510(k) number is K191192.

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

SurgTech GENOLL Total Knee System received FDA 510(k) clearance on 2019-08-01, under 510(k) number K191192.

Who is the listed applicant for SurgTech GENOLL Total Knee System?

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

What is the FDA product code for SurgTech GENOLL Total Knee System?

The FDA product code for SurgTech GENOLL Total Knee System is JWH.

Other records listing Surgtech, 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.

K173455SurgTech Bipolar Head SystemK162125MALUC™ Total Hip Arthroplasty SystemK163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemK161894SurgTech Trauma SystemK152200SurgTech Interbody System

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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