MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER— 510(k) K874503

Name: FDA 510(k) clearance K874503
Creator: U.S. Food and Drug Administration
Published: 1987-12-02

Substantially Equivalent

Micro-Aire Surgical Instruments, Inc.

FDA 510(k) clearance K874503 for MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER, Substantially Equivalent on 1987-12-02. Applicant: Micro-Aire Surgical Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Micro-Aire Surgical Instruments, Inc.
Product code: Code HWM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1987-11-02
Decision date: 1987-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Fernando, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWM

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K870780 — ACROMED WALLIE-HEINIG OSTEOTOMES1987-03-09
K771744 — OSTEOTOMES FOR CUTTING BONH1977-09-28

More clearances from Micro-Aire Surgical Instruments, Inc.

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K904949 — A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS1990-11-26
K902676 — MICROGUARD, ORTHOPEDIC PIN PROTECTORS1990-09-14
K903650 — OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-3051990-09-14
K903713 — OSTEOTOME MODEL NUMBERS 2500-228 & 2500-2291990-09-14
K903664 — MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL1990-09-13

Adverse events under product code HWM

product code HWM

Other: 1
Total: 1

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.