Name: Predicase
Price: 199 USD

K-number	K242350
Device name	Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
Applicant	Spinal Alignment Solutions, Inc.
Product code	NKB
Device class	Class II
Decision date	Oct 28, 2024
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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Spinal Alignment Solutions Pelvic Incidence (PI) Rod System

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