Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System— 510(k) K151064

Name: FDA 510(k) clearance K151064
Creator: U.S. Food and Drug Administration
Published: 2015-08-12

Substantially Equivalent

Biomet Spine

FDA 510(k) clearance K151064 for Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System, Substantially Equivalent on 2015-08-12. Applicant: Biomet Spine. Device class: 2.

Clearance details

Applicant: Biomet Spine
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2015-04-20
Decision date: 2015-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomfield, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVE

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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

More clearances from Biomet Spine

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K152622 — Alta ACDF System2016-07-08
K151974 — Polaris Spinal System2015-11-13
K151224 — Lineum OCT Spine System2015-06-30
K141791 — BIOMET FUSION SYSTEM2014-10-09
K121130 — POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS2012-06-15

Adverse events under product code OVE

product code OVE

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.