CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW— 510(k) K871037

Name: FDA 510(k) clearance K871037
Creator: U.S. Food and Drug Administration
Published: 1987-03-25

Substantially Equivalent

Concept, Inc.

FDA 510(k) clearance K871037 for CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW, Substantially Equivalent on 1987-03-25. Applicant: Concept, Inc.. Device class: 2.

Clearance details

Applicant: Concept, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1987-03-17
Decision date: 1987-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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K896648 — CONCEPT UNICOMPARTMENTAL KNEE SYSTEM1990-06-05
K894929 — STAPLE FIXATION SYSTEM1989-08-30
K892376 — INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)1989-08-01

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.