SYNTHES OC FUSION AND SYNAPSE SYSTEMS— 510(k) K072434

Name: FDA 510(k) clearance K072434
Creator: U.S. Food and Drug Administration
Published: 2008-01-10

Substantially Equivalent

Synthes Spine Co.Lp

FDA 510(k) clearance K072434 for SYNTHES OC FUSION AND SYNAPSE SYSTEMS, Substantially Equivalent on 2008-01-10. Applicant: Synthes Spine Co.Lp. Device class: 2.

Clearance details

Applicant: Synthes Spine Co.Lp
Product code: Product code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2007-08-29
Decision date: 2008-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System2016-04-04

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K112068 — SYNTHES ZERO-P VARIABLE ANGLE (VA)2011-11-07
K103320 — SYNTHES XRL2011-10-20
K081568 — ANTEGRA-T2008-09-02

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.