← FDA Medical Device Classifications

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

KWS · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3660

Classification

FDA Product Code

KWS

Device class

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

Regulation

21 CFR 888.3660

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

190

Registered establishments

218

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown