DeviceClearance

STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS— 510(k) K863734

Substantially Equivalent

Micro-Aire Surgical Instruments, Inc.

FDA 510(k) clearance K863734 for STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS, Substantially Equivalent on 1986-10-20. Applicant: Micro-Aire Surgical Instruments, Inc.. Device class: 2.

Clearance details

Applicant
Micro-Aire Surgical Instruments, Inc.
Product code
Code HTY
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Fernando, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HTY

product code HTY
Injury
544
Total
544

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K863734

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K863734.

Data sourced from openFDA. This site is unofficial and independent of the FDA.