MCGRATH ORTHOPAEDIC BONE SCREWS— 510(k) K901814

Substantially Equivalent for Some Indications

Mcgrath Surgical , Ltd.

FDA 510(k) clearance K901814 for MCGRATH ORTHOPAEDIC BONE SCREWS, Substantially Equivalent for Some Indications on 1990-08-21. Applicant: Mcgrath Surgical , Ltd..

Clearance details

Applicant: Mcgrath Surgical , Ltd.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1990-04-23
Decision date: 1990-08-21
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Po3 5hl England, GB

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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.