510(k) K092521

ZUMA-C by Seaspine, Inc. — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 13, 2010
Date Received: August 18, 2009
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 Seaspine, Inc.

K231654 — NorthStar OCT System (August 3, 2023)
K150469 — Integra Laminoplasty System (March 23, 2015)
K142488 — SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, C (December 18, 2014)
K133418 — INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM (May 1, 2014)
K132859 — INTEGRA FACET FIXATION SYSTEM (November 18, 2013)
K121924 — INTEGRA INTERSPINOUS PROCESS SYSTEM (September 4, 2013)
K130830 — INTEGRA LAMINOPLASTY SYSTEM (May 9, 2013)
K122571 — MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM (December 12, 2012)
K112206 — CARDIFF ANTERIOR CERVICAL PLATE SYSTEM (January 25, 2012)
K111671 — SEASPINE MONOPOLAR PROBE SYSYEM (December 28, 2011)

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)