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

Classification

FDA Product Code

HTO

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

14

Registered establishments

351

Source

Authoritative

FDA Device Classification database

Machine

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