CHISEL, BONE, SURGICAL— 510(k) K901511

Name: FDA 510(k) clearance K901511
Creator: U.S. Food and Drug Administration
Published: 1990-09-28

Substantially Equivalent

Mumtaz I. Malik

FDA 510(k) clearance K901511 for CHISEL, BONE, SURGICAL, Substantially Equivalent on 1990-09-28. Applicant: Mumtaz I. Malik. Device class: 1.

Clearance details

Applicant: Mumtaz I. Malik
Product code: Code LXH
Device class: Class 1
Regulation: 21 CFR 888.4540
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 ↗

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More clearances from Mumtaz I. Malik

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K901289 — RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS1990-09-28
K901420 — VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 81990-09-28
K901521 — OSTEOTOMES OF VARIOUS TYPES1990-09-28
K893902 — 4 X 4 STERILE GAUZE SPONGE TRAY1989-07-14
K890071 — STERILE LACERATION TRAY1989-01-24

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.