← FDA Medical Device Classifications

Methyl Methacrylate For Cranioplasty

GXP · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5300

Classification

FDA Product Code

GXP

Device class

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

Regulation

21 CFR 882.5300

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

43

Registered establishments

39

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown