FDA device listing

Zimmer (WP,DK) - NG COMPLETE KNEE SOLUTION PS-CR BASE NO. 5970, 5971, 5972, 5980, 5982

FDA device listing 1286457744 · STERIS Corporation

Key facts

Proprietary names Zimmer (WP,DK) - NG COMPLETE KNEE SOLUTION PS-CR BASE NO. 5970, 5971, 5972, 5980, 5982
Owner/operator STERIS Corporation
Owner/operator number 10042227
Product codes JWH
Device names JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class Class II
Classification regulations (21 CFR) 888.3560
Review panels Orthopedic
Registered establishments STERIS Schweiz AG, Synergy Health Westport Ltd
Establishment registrations 8043792, 3010173425
FEI numbers 3002807036, 3002808269
Establishment operations Contract Sterilizer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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