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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Archer PSI System
Classification Name: SHOULDER ARTHROPLASTY IMPLANTATION SYSTEM
Product Code: QHE
Device Class: 2
Regulation Number: 888.3660
Medical Specialty: Orthopedic
Registered Establishment Name: 3D-SIDE
Registered Establishment Number: 3013561205
Premarket Submission Number: K243509
Owner/Operator: 3D-Side
Owner/Operator Number: 10054501
Establishment Operations: Manufacturer
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