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Ankle Arthroplasty Implantation System

FDA product code OYK · 7 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3110
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-11-09 – 2024-10-25

Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing.

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