Atlas FDA

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee

FDA 510(k) clearance K222056 · decided 2023-01-26

Clearance details

K-number
K222056
Device name
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
Applicant
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Decision
Substantially Equivalent
Date received
2022-07-12
Decision date
2023-01-26
Days to decision
198 days
Clearance type
Traditional
Product code
JDI
Device class
2
Regulation number
888.3350
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mahwah, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Spec recall (Z-2732-2024)Howmedica Osteonics Corp.2024-08-26