Name: Predicase
Price: 199 USD

K-number	K222572
Device name	FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar Plate System
Applicant	Dio Medical Corporation
Product code	KWQ
Device class	Class II
Decision date	Oct 18, 2022
Decision	Substantially Equivalent
Regulation	888.3060

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Source

View the full FDA submission: accessdata.fda.gov

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FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar Plate System

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FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar Plate System