SYNTHES ZERO-P VARIABLE ANGLE (VA)— 510(k) K112068

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

2011-07-20

Decision date

2011-11-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

West Chester, PA, US

• 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

• K121852 — SYNTHES ZERO-P VARIABLE ANGLE (VA)2012-07-25
• K112459 — SYNTHES ZERO-P2011-12-12
• K103320 — SYNTHES XRL2011-10-20
• K081568 — ANTEGRA-T2008-09-02
• K080020 — ARCOFIX2008-05-23

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 →

• Z-0455-2014 — Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1.Class II·Terminated·Synthes USA HQ, Inc.·20130930

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112068.