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510(k) K211323

ASTRA Spine System by Spinecraft, LLC — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2021
Date Received
April 30, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Spinecraft, LLC

  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K223301 — ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments (July 20, 2023)
  • K223273 — ASTRA Spine System (December 22, 2022)
  • K211935 — ORIO-Ti Intervertebral Body Fusion Cage System (September 30, 2021)
  • K181350 — ASTRA-OCT Spine System (July 6, 2018)
  • K143683 — APEX-DL Spine System (May 22, 2015)
  • K150417 — ASTRA SPINE SYSTEM (May 19, 2015)
  • K131521 — VELOX ANTERIOR CERVICAL PLATE SYSTEM (December 24, 2013)
  • K132603 — APEX SPINE SYSTEM (November 20, 2013)
  • K110906 — APEX SPINE SYSTEM (July 26, 2011)

Other clearances for product code NKB

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)