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FDA 510(k)

MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER

K-Number: K821695 · 1982-07-20

ApplicantMicro-Aire Surgical Instruments, Inc.
Decision Date1982-07-20
Product CodeHTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER 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 1982-07-20 under 510(k) number K821695. The device is classified under product code HTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER?

MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER is a medical device that received FDA 510(k) clearance on 1982-07-20. The listed applicant is Micro-Aire Surgical Instruments, Inc.. The 510(k) number is K821695.

When did MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER receive FDA 510(k) clearance?

MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER received FDA 510(k) clearance on 1982-07-20, under 510(k) number K821695.

Who is the listed applicant for MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER?

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 REPLAC. DRILL BURS FOR ZIMMER?

The FDA product code for MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER is HTT.

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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: HTT)

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.

K862529HALL STERILE BURHall Surgical, Division of Zimmer, Inc.K802598CARBIDE CUTTING INSTRUMENT/INTRAARTICUThe Anspach Effort, Inc.K760236BUR, SURGICAL CARBIDECutter Laboratories, 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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