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510(k) K172833

E-XPE Acetabular Components and U-Motion II Acetabular Cup by United Orthopedic Corporation — Product Code OQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2018
Date Received
September 19, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.

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Other clearances for product code OQI

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