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FDA 510(k)

BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500

K-Number: K900210 · 1990-02-02

ApplicantMicro-Aire Surgical Instruments, Inc.
Decision Date1990-02-02
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 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 1990-02-02 under 510(k) number K900210. The device is classified under product code HSZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500?

BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 is a medical device that received FDA 510(k) clearance on 1990-02-02. The listed applicant is Micro-Aire Surgical Instruments, Inc.. The 510(k) number is K900210.

When did BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 receive FDA 510(k) clearance?

BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 received FDA 510(k) clearance on 1990-02-02, under 510(k) number K900210.

Who is the listed applicant for BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500?

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 BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500?

The FDA product code for BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 is HSZ.

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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: HSZ)

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.

K991588EMS SWISS ORTHOCLAST(Ems Sa) Electro Medical SystemsK972860CURVTEK TSR SYSTEMBiolectron, Inc.K970345ALIGNMENT INSTRUMENTRichard Wolf Medical Instruments Corp.K955084ASPACH 65,000 (MODIFICATION)The Anspach Effort, Inc.K954080SODEM HIGH SPEED SYSTEMSodem Diffusion SAK944590ETHICON DRILL BIT AND DRILL GUIDEETHICON, 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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