510(k) K171489

Acapella Cervical Spacer System by Choicespine, LP — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 23, 2017
Date Received: May 22, 2017
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

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

Intended to stabilize cervical 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)
K180519 — HARRIER-SA Lumbar Interbody System (May 16, 2018)
K172816 — TiGer Shark System (January 26, 2018)
K173215 — Choice Spine Laminoplasty Fixation System (January 19, 2018)
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 OVE

K260038 — E3D-C Interbody System (February 4, 2026)
K253876 — HEDRON Cervical Spacers (HEDRON C-MIS Spacer) (December 22, 2025)
K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
K250076 — Endeavor Stand-Alone Cervical IBF System (September 25, 2025)
K250540 — SABER-C System (August 8, 2025)
K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs) (July 30, 2025)
K251431 — FIX-C PEEK ACIF SA System (June 27, 2025)
K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
K242928 — Tesera-k SC System (April 10, 2025)
K243188 — CYLOX® ST (February 11, 2025)