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Shoulder Arthroplasty Implantation System

FDA product code QHE · 26 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3660
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-08-30 – 2026-06-09

Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

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