← FDA Medical Device Classifications

Glenoid Fossa Prosthesis

MPI · Class III — High Risk (PMA approval required, life-sustaining) · Dental · 21 CFR 872.3950

Classification

FDA Product Code
MPI
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 872.3950
Review panel
DE
Medical specialty
Dental
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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