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FDA 510(k)

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous

K-Number: K162256 · 2016-10-27

ApplicantTotal Joint Orthopedics, Inc.
Decision Date2016-10-27
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-10-27 under 510(k) number K162256. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Klassic Femur, Porous, Klassic Tibial Baseplate, Porous?

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K162256.

When did Klassic Femur, Porous, Klassic Tibial Baseplate, Porous receive FDA 510(k) clearance?

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous received FDA 510(k) clearance on 2016-10-27, under 510(k) number K162256.

Who is the listed applicant for Klassic Femur, Porous, Klassic Tibial Baseplate, Porous?

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

What is the FDA product code for Klassic Femur, Porous, Klassic Tibial Baseplate, Porous?

The FDA product code for Klassic Femur, Porous, Klassic Tibial Baseplate, Porous is MBH.

Other records listing Total Joint Orthopedics, 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.

K261734Klassic Infection Spacer SystemK220483Platform® Acetabular SystemK211877Klassic Knee SystemK211602Klassic Knee SystemK202740Klassic Knee System Tibial Inserts, PS-MaxK183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly

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Related Devices (Code: MBH)

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.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

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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