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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: HeliFix Interspinous Spacer System
Classification Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Product Code: NQO
Device Class: 3
Registered Establishment Name: ALPHATEC SPINE, INC.
Registered Establishment Number: 2027467
Owner/Operator: ALPHATEC HOLDINGS, INC.
Owner/Operator Number: 9072657
Establishment Operations: U.S. Manufacturer of Export Only Devices
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