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510(k) K150049

PASS LP Spinal System by Medicrea International — Product Code MNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2015
Date Received
January 12, 2015
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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Other clearances for product code MNI

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  • K160731 — LumFix Spinal Fixation Sytem (October 4, 2016)
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  • K160320 — Premier (April 1, 2016)
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  • K143222 — FIREFLY Pedicle Screw Navigation Guide (December 11, 2015)
  • K150684 — WASTON General Spinal System (November 18, 2015)