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510(k) K153446

OLYMPIC Posterior Spinal Fixation System by Astura Medical — Product Code OSH

K153446 is an FDA 510(k) premarket notification submitted by Astura Medical for the device "OLYMPIC Posterior Spinal Fixation System". The FDA issued a decision of Substantially Equivalent on April 8, 2016. The device falls under product code OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis), a Class II device regulated under 21 CFR 888.3070. Astura Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2016
Date Received
November 27, 2015
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 Astura Medical

  • K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (January 22, 2026)
  • K252346 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (October 21, 2025)
  • K243259 — MASADA Modular Spinal Fixation System (January 7, 2025)
  • K240160 — EGPS Navigated Instruments (October 17, 2024)
  • K233359 — DOMINION Expandable Corpectomy System (March 8, 2024)
  • K231694 — MASADA Modular Spinal Fixation System (November 16, 2023)
  • K232211 — REUNION Sacroiliac Joint Fusion System (October 24, 2023)
  • K223335 — SIRION Lateral Lumbar Interbody System (May 9, 2023)
  • K222097 — OLYMPIC Deformity Band System (May 4, 2023)
  • K222554 — EL CAPITAN Anterior Lumbar Interbody Fusion (January 19, 2023)

Other clearances for product code OSH

  • 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)
  • K131030 — RANGE SPINAL SYSTEM (May 9, 2013)

FDA data resources