CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE— 510(k) K102323

Name: FDA 510(k) clearance K102323
Creator: U.S. Food and Drug Administration
Published: 2010-12-16

Substantially Equivalent

Theken Spine, LLC

FDA 510(k) clearance K102323 for CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE, Substantially Equivalent on 2010-12-16. Applicant: Theken Spine, LLC. Device class: 2.

Clearance details

Applicant: Theken Spine, LLC
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2010-08-17
Decision date: 2010-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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K120829 — STAINLESS STEEL SPINAL SYSTEM2012-05-30
K120047 — CORAL SPINAL SYSTEM2012-02-03
K111675 — VU C*POD INTERVERTEBRAL BODY FUSION DEVICE2011-08-02

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.