510(k) K180519

HARRIER-SA Lumbar Interbody System by Choicespine, LP — Product Code OVD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 16, 2018
Date Received: February 27, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by Choicespine, LP

K190227 — Boomerang Anterior Cervical Plate System (May 1, 2019)
K183397 — ChoiceSpine Stealth Cervical Spacer System (March 6, 2019)
K183588 — Choice Spine Hawkeye Vertebral Body Replacement (VBR) System (February 22, 2019)
K182721 — Choice Spine Navigation System (January 8, 2019)
K183214 — Raven Lumbar Plate System (January 3, 2019)
K172816 — TiGer Shark System (January 26, 2018)
K173215 — Choice Spine Laminoplasty Fixation System (January 19, 2018)
K171489 — Acapella Cervical Spacer System (October 23, 2017)
K171686 — Choice Spine Hawkeye Vertebral Body Replacement (VBR) System (September 15, 2017)
K171456 — Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems (August 3, 2017)

Other clearances for product code OVD

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K250072 — CONDUIT SYNFIX Evolution Secured Spacer System (July 10, 2025)
K251644 — ProAM ALIF System (June 24, 2025)
K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
K251459 — OneLIF Interbody Fusion System (June 12, 2025)
K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
K243386 — Ventris Intervertebral Body Fusion Device (April 22, 2025)
K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)