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Klassic Knee System - Klassic Knee PS-Post Femur +2 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183596

by Total Joint Orthopedics, Inc.

Identifiers

510(k) Number
K183596 FDA 510(k)
FDA Product Code
JWH FDA 510(k)
Models / Variants
Klassic Knee System - Klassic Knee PS-Post Femur FDA 510(k)
Klassic Knee Tibial Insert, PS-Post, Std Poly FDA 510(k)
Klassic Knee Tibial Insert, PS-Post, E-Link Poly FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3560 FDA 510(k)
Regulation Number
888.3560 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Klassic Knee System - Klassic Knee PS-Post Femur +2 more models by Total Joint Orthopedics, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Total Joint Orthopedics, Inc.

Sources (1)

  • FDA 510(k) K183596 24 fields · synced Jun 18, 2026