Name: Predicase
Price: 199 USD

K-number	K233414
Device name	Shoreline ACS Interbody System; Shoreline RT Interbody System
Applicant	SeaSpine Orthopedics Corporation
Product code	OVE
Device class	Class II
Decision date	Nov 28, 2023
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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Shoreline ACS Interbody System; Shoreline RT Interbody System

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