Name: Predicase
Price: 199 USD

K-number	K210595
Device name	SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers
Applicant	Camber Spine Technologies, LLC
Product code	MAX
Device class	Class II
Decision date	Jun 15, 2021
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers

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