Name: Predicase
Price: 199 USD

K-number	K231839
Device name	CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System
Applicant	L&K BIOMED Co., Ltd.
Product code	KWQ
Device class	Class II
Decision date	Jul 19, 2023
Decision	Substantially Equivalent
Regulation	888.3060

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Source

View the full FDA submission: accessdata.fda.gov

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CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System

Everything you need for a 510(k) submission. Nothing you don't.