SOLITAIRE-C CERVICAL SPACER SYSTEM— 510(k) K113796

Clearance details

Applicant

Ebi, LLC

Product code

Code OVE

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2011-12-23

Decision date

2012-04-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Parsippany, NJ, US

• K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
• K261451 — ZSAlign Cervical Interbody System2026-07-31
• K262094 — E3D-C Interbody System2026-07-22
• K261279 — DeltaNEC Interbody System2026-06-22
• K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

• K140734 — NEXTGEN ALTIUS OCT SYSTEM2014-12-15
• K140123 — POLARIS SPINAL SYSTEM -TRANSLATION SCREW2014-04-24
• K111376 — CONSTRUX EXTERNAL FIXATION DEVICE2011-08-03

Injury

293

Malfunction

710

Total

1,003

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0874-2015 — Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve 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.Class II·Terminated·Ebi, Llc·20141111

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113796.