← FDA Medical Device Classifications

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

JDL · Class III — High Risk (PMA approval required, life-sustaining) · Orthopedic · 21 CFR 888.3320

Classification

FDA Product Code

JDL

Device class

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

Regulation

21 CFR 888.3320

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

45

Registered establishments

49

Source

Authoritative

FDA Device Classification database

Machine

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