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FDA 510(k)

TK1 TOTAL KNEE SYSTEM

K-Number: K123339 · 2013-04-11

ApplicantNovosource, Inc.
Decision Date2013-04-11
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TK1 TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Novosource, Inc.. It received FDA 510(k) clearance on 2013-04-11 under 510(k) number K123339. 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 TK1 TOTAL KNEE SYSTEM?

TK1 TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-11. The listed applicant is Novosource, Inc.. The 510(k) number is K123339.

When did TK1 TOTAL KNEE SYSTEM receive FDA 510(k) clearance?

TK1 TOTAL KNEE SYSTEM received FDA 510(k) clearance on 2013-04-11, under 510(k) number K123339.

Who is the listed applicant for TK1 TOTAL KNEE SYSTEM?

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

What is the FDA product code for TK1 TOTAL KNEE SYSTEM?

The FDA product code for TK1 TOTAL KNEE SYSTEM is JWH.

Related Clinical Trials

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Other records listing Novosource, 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.

K131398NOVOKNEE TOTAL KNEE 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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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