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FDA 510(k)

MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER

K-Number: K874503 · 1987-12-02

ApplicantMicro-Aire Surgical Instruments, Inc.
Decision Date1987-12-02
Product CodeHWM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Aire Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1987-12-02 under 510(k) number K874503. The device is classified under product code HWM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER?

MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER is a medical device that received FDA 510(k) clearance on 1987-12-02. The listed applicant is Micro-Aire Surgical Instruments, Inc.. The 510(k) number is K874503.

When did MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER receive FDA 510(k) clearance?

MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER received FDA 510(k) clearance on 1987-12-02, under 510(k) number K874503.

Who is the listed applicant for MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER?

The FDA 510(k) record lists Micro-Aire Surgical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER?

The FDA product code for MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER is HWM.

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Other records listing Micro-Aire Surgical Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K904949A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERSK903713OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229K902676MICROGUARD, ORTHOPEDIC PIN PROTECTORSK903650OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305K903664MICRO-AIRE WIRE PASS AND CRANIOTOME DRILLK901967DENDIA WERK BURS AND CUTTING DISCS

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Related Devices (Code: HWM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K870780ACROMED WALLIE-HEINIG OSTEOTOMESBuckman Co., Inc.K771744OSTEOTOMES FOR CUTTING BONHDepuy, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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