← FDA Medical Device Classifications

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HSR · Class I — Low Risk (general controls) · Orthopedic · 21 CFR 888.5890

Classification

FDA Product Code

HSR

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 888.5890

Review panel

OR

Medical specialty

Orthopedic

Submission type

4

GMP exempt

Y

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

1

Registered establishments

7

Source

Authoritative

FDA Device Classification database

Machine

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