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Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented

FDA product code PAO · 1 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3660
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-09-11 – 2020-09-11

Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.

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