Norian Reinforced, Norian Reinforced Fast Set Putty

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K102018 ↗

FDA Product Code

GXP

FDA applicant

Synthes USA Products, LLC

Device Class

Class II

Regulation

21 CFR Part 882.5300

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Synthes (USA) Products LLC →