Ankle Arthroplasty Implantation System

OYK · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3110

Classification

FDA Product Code: OYK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3110
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 7
Registered establishments: 10

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown