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Knee Arthroplasty Implantation System

FDA product code OOG · 2 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3560
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2021-04-19 – 2023-12-20

Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

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