MICRO-AIRE REPLACEMENT SURG. SAW BLADE— 510(k) K831714

Clearance details

Applicant

Micro-Aire Surgical Instruments, Inc.

Product code

Code GFA

Device class

Class 1

Regulation

21 CFR 878.4820

Advisory panel

General, Plastic Surgery

Date received

1983-05-27

Decision date

1983-07-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

• K971978 — GRAFT HARVESTING SAWBLADES1997-06-18
• K954483 — STRYKER SAGITTAL SAW ATTACHMENT1996-01-30
• K955229 — WRIGHT MEDICAL TECHNOLOGY SAWBLADES1996-01-18
• K953012 — DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS1995-07-12
• K950403 — SURGICAL SAW BLADES1995-02-21

• 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

Death

2

Injury

140

Malfunction

2,337

Total

2,479

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 →