Home / 510(k) Clearances / K241276

510(k) K241276

Vector™ Pedicle Screw System by Innovasis, Inc. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2024
Date Received
May 6, 2024
Clearance Type
Traditional
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 Innovasis, Inc.

  • K250076 — Endeavor™ Stand-Alone Cervical IBF System (September 25, 2025)
  • K251073 — Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Exce (July 23, 2025)
  • K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)
  • K250182 — Innovasis Navigation Instruments (March 24, 2025)
  • K231899 — HAtetracell™-C Titanium Cervical IBF System (October 17, 2023)
  • K223511 — Excella Navigation Instruments (May 2, 2023)
  • K223510 — Matrix HA Fusion Porous Cervical IBF System (December 12, 2022)
  • K220875 — HAcancellous PEEK-C Porous HA PEEK Cervical IBF System (August 26, 2022)
  • K212967 — AxTiHA Stand-Alone ALIF System (October 15, 2021)
  • K201614 — TxTiHA IBF System, AxTiHA Stand-Alone ALIF System (July 15, 2020)

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)