SYNTHES ZERO-P VARIABLE ANGLE (VA)— 510(k) K121852

Name: FDA 510(k) clearance K121852
Creator: U.S. Food and Drug Administration
Published: 2012-07-25

Substantially Equivalent

Synthes Spine Co.Lp

FDA 510(k) clearance K121852 for SYNTHES ZERO-P VARIABLE ANGLE (VA), Substantially Equivalent on 2012-07-25. Applicant: Synthes Spine Co.Lp. Device class: 2.

Clearance details

Applicant: Synthes Spine Co.Lp
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2012-06-25
Decision date: 2012-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVE

view all

K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
K261451 — ZSAlign Cervical Interbody System2026-07-31
K262094 — E3D-C Interbody System2026-07-22
K261279 — DeltaNEC Interbody System2026-06-22
K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

More clearances from Synthes Spine Co.Lp

view all

K112459 — SYNTHES ZERO-P2011-12-12
K112068 — SYNTHES ZERO-P VARIABLE ANGLE (VA)2011-11-07
K103320 — SYNTHES XRL2011-10-20
K081568 — ANTEGRA-T2008-09-02
K080020 — ARCOFIX2008-05-23

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.