← FDA Medical Device Classifications

Brace, Drill

HXY · Class I — Low Risk (general controls) · Orthopedic · 21 CFR 888.4540

Classification

FDA Product Code

HXY

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 888.4540

Review panel

OR

Medical specialty

Orthopedic

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

7

Registered establishments

90

Source

Authoritative

FDA Device Classification database

Machine

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