FDA product code OYK

Ankle Arthroplasty Implantation System

Orthopedic·Class 2·21 CFR 888.3110
US regulatory classifications
US Product Code (FDA)
OYK
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.3110
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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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About this record

Ankle Arthroplasty Implantation System is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.