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FDA 510(k)

OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229

K-Number: K903713 · 1990-09-14

ApplicantMicro-Aire Surgical Instruments, Inc.
Decision Date1990-09-14
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 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 1990-09-14 under 510(k) number K903713. 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 OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229?

OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 is a medical device that received FDA 510(k) clearance on 1990-09-14. The listed applicant is Micro-Aire Surgical Instruments, Inc.. The 510(k) number is K903713.

When did OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 receive FDA 510(k) clearance?

OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 received FDA 510(k) clearance on 1990-09-14, under 510(k) number K903713.

Who is the listed applicant for OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229?

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 OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229?

The FDA product code for OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 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 NUMBERSK903650OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305K902676MICROGUARD, ORTHOPEDIC PIN PROTECTORSK903664MICRO-AIRE WIRE PASS AND CRANIOTOME DRILLK901967DENDIA WERK BURS AND CUTTING DISCSK901735ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444

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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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