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HSA · registration DE0016721

Zimmer® NexGen® Complete Knee Solution, LPS-Flex Knee Arthroplasty System

SingaporeOrthopaedicsClass CZimmer Inc
Official record identity
Registration number
DE0016721
Model identifier
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Registration date
January 05, 2015
Source update date
November 24, 2021
Classification
Risk class
Class C
Official value: CLASS C
Published category
Orthopaedics
Published parties
Product owner
Zimmer Inc
Registrant / registration holder
ZIMMER PTE. LTD.
Official description

Intended for use in total knee arthroplasty and is indicated for use in patients with severe knee pain and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; collagen disorders, and/or avascular necrosis of the femoral condyle; post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; moderate valgus, varus, or flexion deformities; the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

Additional source fields
Product owner address
1800 West Centre Street, Warsaw IN 46580, United States
Registrant address
401 COMMONWEALTH DRIVE, #06-03, HAW PAR TECHNO CENTRE, Singapore 149598
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.