K-number	K043349
Device name	OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)
Applicant	Ldr Spine USA
Product code	MQP
Device class	Class II
Decision date	Jun 29, 2005
Decision	Substantially Equivalent
Regulation	888.3060

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View the full FDA submission: accessdata.fda.gov

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OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)

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