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510(k) K222097

OLYMPIC Deformity Band System by Astura Medical — Product Code OWI

K222097 is an FDA 510(k) premarket notification submitted by Astura Medical for the device "OLYMPIC Deformity Band System". The FDA issued a decision of Substantially Equivalent on May 4, 2023. The device falls under product code OWI (Bone Fixation Cerclage, Sublaminar), a Class II device regulated under 21 CFR 888.3010. Astura Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2023
Date Received
July 18, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Fixation Cerclage, Sublaminar
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type

Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.

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)
  • K222554 — EL CAPITAN Anterior Lumbar Interbody Fusion (January 19, 2023)
  • K214047 — EL CAPITAN Anterior Lumbar Interbody Fusion System (March 30, 2022)

Other clearances for product code OWI

  • K261374 — LigaPASS™ System (May 27, 2026)
  • K253615 — Invictus Bands System (March 25, 2026)
  • K230565 — HILINE™ Fixation System (April 20, 2023)
  • K213659 — LigaPASS™ 2.0 Ligament Augmentation System (May 24, 2022)
  • K211057 — LigaPASS® Spinal System, CD Horizon™ Spinal System (May 27, 2021)
  • K201240 — Mariner Cap System (August 5, 2020)
  • K200281 — The Gecko Spinal System (March 31, 2020)
  • K200097 — Response BandLoc Spinal Fixation (March 16, 2020)
  • K191217 — JAZZ PF (August 2, 2019)
  • K190289 — Karma® Fixation System (April 3, 2019)

FDA data resources