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510(k) K102331

LDR SPINE USA SPINETUNE TL SPINAL SYSTEM by Ldr Spine USA — Product Code MNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2010
Date Received
August 17, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spinal Pedicle Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

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