← FDA Medical Device Classifications

Device, Fixation, Proximal Femoral, Implant

JDO · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3030

Classification

FDA Product Code
JDO
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 888.3030
Review panel
OR
Medical specialty
Orthopedic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

Market data

Cleared 510(k) submissions
23
Registered establishments
60

Source

Authoritative
FDA Device Classification database
Machine
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