SYNTHES ZERO-P— 510(k) K072981

Substantially Equivalent

Synthes Spine Co.Lp

FDA 510(k) clearance K072981 for SYNTHES ZERO-P, Substantially Equivalent on 2008-02-11. Applicant: Synthes Spine Co.Lp.

Clearance details

Applicant: Synthes Spine Co.Lp
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2007-10-23
Decision date: 2008-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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.