K-number	K141253
Device name	NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
Applicant	New Era Orthopaedics, LLC
Product code	MNI
Device class	Class II
Decision date	Jan 9, 2015
Decision	Substantially Equivalent
Regulation	888.3070

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Source

View the full FDA submission: accessdata.fda.gov

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NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM

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