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FDA 510(k)

MICROAIRE(R) FACIAL BONE PLATING SYSTEM

K-Number: K914998 · 1992-06-02

ApplicantMicro Surgical Instruments Corp.
Decision Date1992-06-02
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICROAIRE(R) FACIAL BONE PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Micro Surgical Instruments Corp.. It received FDA 510(k) clearance on 1992-06-02 under 510(k) number K914998. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROAIRE(R) FACIAL BONE PLATING SYSTEM?

MICROAIRE(R) FACIAL BONE PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-06-02. The listed applicant is Micro Surgical Instruments Corp.. The 510(k) number is K914998.

When did MICROAIRE(R) FACIAL BONE PLATING SYSTEM receive FDA 510(k) clearance?

MICROAIRE(R) FACIAL BONE PLATING SYSTEM received FDA 510(k) clearance on 1992-06-02, under 510(k) number K914998.

Who is the listed applicant for MICROAIRE(R) FACIAL BONE PLATING SYSTEM?

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

What is the FDA product code for MICROAIRE(R) FACIAL BONE PLATING SYSTEM?

The FDA product code for MICROAIRE(R) FACIAL BONE PLATING SYSTEM is HRS.

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Other records listing Micro Surgical Instruments Corp. 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.

K931395SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEMK932492IMPLANTOLOGY MODULE, MODEL 2175K930205ELECTRIC WIRE DRIVER, MODEL 2640EK915139MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULEK914346DRILL MODULES MODELS 2116/2117K913369MICRO-AIRE MODEL 2060

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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