ORACLE SPACER, OPAL SPACER— 510(k) K072791

Substantially Equivalent

Synthes Spine

FDA 510(k) clearance K072791 for ORACLE SPACER, OPAL SPACER, Substantially Equivalent on 2007-12-26. Applicant: Synthes Spine.

Clearance details

Applicant: Synthes Spine
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2007-10-01
Decision date: 2007-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.