CHISEL, BONE, SURGICAL— 510(k) K901511

Substantially Equivalent

Mumtaz I. Malik

FDA 510(k) clearance K901511 for CHISEL, BONE, SURGICAL, Substantially Equivalent on 1990-09-28. Applicant: Mumtaz I. Malik.

Clearance details

Applicant: Mumtaz I. Malik
Product code: Code LXH
Advisory panel: Orthopedic
Date received: 1990-03-29
Decision date: 1990-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elizabethtown, KY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LXH

product code LXH

Death: 11
Injury: 2,218
Malfunction: 31,318
Total: 33,547

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.