ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL— 510(k) K101588

Substantially Equivalent

Apollo Spine, Inc.

FDA 510(k) clearance K101588 for ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL, Substantially Equivalent on 2011-01-07. Applicant: Apollo Spine, Inc..

Clearance details

Applicant: Apollo Spine, Inc.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2010-06-07
Decision date: 2011-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoughton, MA, US

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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.