← FDA Medical Device Classifications

Fastener, Plate, Cranioplasty

HBW · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5360

Classification

FDA Product Code

HBW

Device class

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

Regulation

21 CFR 882.5360

Review panel

NE

Medical specialty

Neurology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

Y

Third-party review

N

Market data

Cleared 510(k) submissions

7

Registered establishments

34

Source

Authoritative

FDA Device Classification database

Machine

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