Name: Predicase
Price: 199 USD

K-number	K231460
Device name	FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System
Applicant	K&J Consulting Corp.
Product code	KWQ
Device class	Class II
Decision date	Jul 16, 2023
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, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System

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