SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA— 510(k) K870843

Name: FDA 510(k) clearance K870843
Creator: U.S. Food and Drug Administration
Published: 1987-05-27

Substantially Equivalent

Warsaw Orthopedic, Inc.

FDA 510(k) clearance K870843 for SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA, Substantially Equivalent on 1987-05-27. Applicant: Warsaw Orthopedic, Inc.. Device class: 1.

Clearance details

Applicant: Warsaw Orthopedic, Inc.
Product code: Code HWT
Device class: Class 1
Regulation: 21 CFR 888.4800
Advisory panel: Orthopedic
Date received: 1987-03-03
Decision date: 1987-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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K871323 — ARTHROSCOPIC MENISCAL SUTURE SYSTEM1987-05-01
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K880211 — TSRH H/M HOOK HOLDER1988-03-04
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Adverse events under product code HWT

product code HWT

Injury: 218
Malfunction: 12,907
Total: 13,125

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.