Name: Predicase
Price: 199 USD

K-number	K232996
Device name	Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)
Applicant	Shanghai Iatrical-Ti Technologies CO , Ltd.
Product code	MAX
Device class	Class II
Decision date	Sep 6, 2024
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)

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