SYNFIX-LR SPACER— 510(k) K072253

Name: FDA 510(k) clearance K072253
Creator: U.S. Food and Drug Administration
Published: 2007-10-12

Substantially Equivalent

Synthes Spine Co.Lp

FDA 510(k) clearance K072253 for SYNFIX-LR SPACER, Substantially Equivalent on 2007-10-12. Applicant: Synthes Spine Co.Lp. Device class: 2.

Clearance details

Applicant: Synthes Spine Co.Lp
Product code: Product code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2007-08-14
Decision date: 2007-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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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 OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.