← FDA Medical Device Classifications

Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

JWJ · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3800

Classification

FDA Product Code

JWJ

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 888.3800

Review panel

OR

Medical specialty

Orthopedic

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

Y

Third-party review

N

Market data

Cleared 510(k) submissions

17

Registered establishments

36

Source

Authoritative

FDA Device Classification database

Machine

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