ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR— 510(k) K102121

Name: FDA 510(k) clearance K102121
Creator: U.S. Food and Drug Administration
Published: 2011-01-12

Substantially Equivalent

Apollo Spine, Inc.

FDA 510(k) clearance K102121 for ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR, Substantially Equivalent on 2011-01-12. Applicant: Apollo Spine, Inc.. Device class: 2.

Clearance details

Applicant: Apollo Spine, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2010-07-29
Decision date: 2011-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoughton, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Apollo Spine, Inc.

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K120340 — VENUS FACET SCREW SYSTEM2012-10-19
K102636 — ZENITH PEDICLE SYSTEM2011-03-03
K101588 — ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL2011-01-07
K090751 — COMET ANTERIOR CERVICAL PLATE SYSTEM2009-10-23
K082504 — APOLLO ANTERIOR CERVICAL PLATE SYSTEM2009-01-27

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.