FDA.reportPublic FDA data

510(k) K243817

Device
Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert ? Cruciate Retaining Insert; Scorpio NRG Tibial Bearing
Applicant
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
510(k) number
K243817
Product code
JWH
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-06
Date received
2024-12-12
Regulation
888.3560
Classification name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tara Rudrapatna
Address
325 Corporate Dr. Mahwah NJ US 07430 07430

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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