← FDA Medical Device Classifications

Trephine

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

Classification

FDA Product Code

HWK

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

1

Registered establishments

122

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown