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510(k) K123138

PASS LP SPINAL SYSTEM by Medicrea International — Product Code OSH

K123138 is an FDA 510(k) premarket notification submitted by Medicrea International for the device "PASS LP SPINAL SYSTEM". The FDA issued a decision of SESU on February 5, 2013. The device falls under product code OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis), a Class II device regulated under 21 CFR 888.3070. Medicrea International has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
February 5, 2013
Date Received
October 5, 2012
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.

Other clearances by Medicrea International

  • K261374 — LigaPASS™ System (May 27, 2026)
  • K213659 — LigaPASS™ 2.0 Ligament Augmentation System (May 24, 2022)
  • K220810 — Infinity™ OCT System and PASS OCT Spinal System (April 19, 2022)
  • K220724 — CD Horizon™ Spinal System and PASS LP™ Spinal System (April 8, 2022)
  • K212005 — UNiD Spine Analyzer (January 12, 2022)
  • K213281 — PASS LP™ Spinal System, CD Horizon™ Spinal System (January 5, 2022)
  • K210470 — C-CURVE Interbody Fusion Device (September 3, 2021)
  • K200316 — UNiD IB3D ALIF (October 30, 2020)
  • K191134 — IB3D ALIF (October 30, 2019)
  • K182158 — UNiD Patient-matched PLIF cage (July 15, 2019)

Other clearances for product code OSH

  • K153446 — OLYMPIC Posterior Spinal Fixation System (April 8, 2016)
  • K140276 — CD HORIZON SPINAL SYSTEM (March 13, 2014)
  • K132574 — PASS LP SPINAL SYSTEM (November 8, 2013)
  • 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)

FDA data resources