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510(k) K132574

PASS LP SPINAL SYSTEM by Medicrea International — Product Code OSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2013
Date Received
August 16, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.

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Other clearances for product code OSH

  • K153446 — OLYMPIC Posterior Spinal Fixation System (April 8, 2016)
  • K140276 — CD HORIZON SPINAL SYSTEM (March 13, 2014)
  • K132303 — IMPLANET SPINE SYSTEM (October 10, 2013)
  • K132575 — PASS LP SPINAL SYSTEM (October 3, 2013)
  • K131802 — EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM (September 12, 2013)
  • K131615 — POLARIS SPINAL SYSTEM (September 4, 2013)
  • K131784 — RANGE SPINAL SYSTEM (August 30, 2013)
  • K131321 — CD HORIZON SPINAL SYSTEM (June 5, 2013)
  • K124058 — CREO STABILIZATION SYSTEM (May 13, 2013)
  • K131030 — RANGE SPINAL SYSTEM (May 9, 2013)