← FDA Medical Device Classifications

Prosthesis, Knee, Hemi-, Femoral

HSA · Class III — High Risk (PMA approval required, life-sustaining) · Orthopedic · 21 CFR 888.3570

Classification

FDA Product Code

HSA

Device class

Class III — High Risk (PMA approval required, life-sustaining)

Regulation

21 CFR 888.3570

Review panel

OR

Medical specialty

Orthopedic

Submission type

2

GMP exempt

N

Life sustaining

N

Implant

Y

Third-party review

N

Market data

Cleared 510(k) submissions

0

Registered establishments

1

Source

Authoritative

FDA Device Classification database

Machine

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