VHS SUPRACONDYLAR PLATE SYSTEM— 510(k) K991806

Name: FDA 510(k) clearance K991806
Creator: U.S. Food and Drug Administration
Published: 1999-08-06

Substantially Equivalent

Walter Abendschein, M.D.

FDA 510(k) clearance K991806 for VHS SUPRACONDYLAR PLATE SYSTEM, Substantially Equivalent on 1999-08-06. Applicant: Walter Abendschein, M.D.. Device class: 2.

Clearance details

Applicant: Walter Abendschein, M.D.
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1999-05-26
Decision date: 1999-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chevy Chase, MD, US

Download summary PDF View on FDA.gov ↗

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More clearances from Walter Abendschein, M.D.

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K000827 — UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED2000-06-23
K964880 — VARI-ANGLE HIP SCREW (VHS) SYSTEM1997-10-16

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.