Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2020601

FEI Number

2020601

Entity Name

MICROAIRE SURGICAL INSTRUMENTS LLC

City/State/Country

CHARLOTTESVILLE, VA, US

Establishment Address

3590 Grand Forks Blvd, CHARLOTTESVILLE, VA 22911, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MICROAIRE SURGICAL INSTRUMENTS, LLC (Owner Number: 9004658)

Owner / Operator Contact Address

3590 GRAND FORKS BOULEVARD, --, Charlottesville, VA 22911, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ENDOTINE FOREHEAD INSTRUMENT KIT AND REPLACEMENT ASSEMBLIES ENDOTINE MIDFACE B INSTRUMENT KIT AND REPLACEMENT ASSEMBLIES Ultratine Forehead MicroAire Rasps SMARTRELEASE Endoscopic Soft Tissue Release System MICROAIRE MANUAL SURGICAL DRILL MicroAire Sterilization Cases (FROM PARAGON) Endotine Ribbon RAIL CLAMP POLE IV POLE BASKET CANISTER RING PAL CART PAL Sterilization Case MicroAire Chisels and Osteotomes Endotine Midface ST MicroAire Twist Drill MicroAire Burs MicroAire Cutters for Midas Rex Inst. 5025 Electric Instrument Console MicroAire Series 5000 Electric 5401 Electric Foot Pedal 5000 ET Electric Motor MicroAire SmartDriver Electric 5130 High Speed Drill Coupler MicroAire Series 7000 Electric SMARTRELEASE Endoscopic Soft Tissue Release System Endotine Triple Endotine Forehead Mini MicroAire Batteries SMARTRELEASE® Endoscopic Soft Tissue Release System MicroAire 7000 Series Electric MicroAire SmartDriver Battery Various Couplers & Modules SURGIWIRE INCISIONLESS DISSECTOR MicroAire Kirschner Wires MicroAire Steinmann Pins 7020-PAL 7020-ASP 7020-PEDAL PAL 7020 Console 7020-INF PAL Multi-Use Infiltration Cannula PAL-INF-RXXXX Infiltration Foot Switch INF-FOOT-1 PAL Single-Use Infiltration Cannula PAL-INF-XXXX PAL Infiltration Pump INF-PUMP Infiltration Pump to 5020 Connection Cable INF-CBL-5020 PAL Infiltration Tubing PAL-INF-1600 Endotine Transbleph MicroAire SmartRelease System Accessories Endotine Forehead PAL Multi-use cannulas and PAL Manual Wand LipoTower PAL Tubing PAL-1200 PAL Console 5020 PAL Cable 5006-PAL PAL Handpiece PAL-650 PAL Disinfection CAP CAP-600E PAL Handpiece PAL-750 Nitrogen Regulators 9500-000, 9502-000 MicroAire Semi-Disposable Pulse Lavage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2011-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2010-09-08
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2010-05-05
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-08-20
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-08-20
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-08-20
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2002-01-04
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2010-12-13
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2010-09-08
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2025-07-14
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2025-07-21
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2010-09-08
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2010-09-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2010-09-08
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2012-09-14
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2013-08-19
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	1992-12-22
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-08-20
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-08-20
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-08-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2010-09-08
MOQ	Battery, Replacement, Rechargeable	General, Plastic Surgery	Class 1	878.4820	2010-09-08
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-03-14
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-03-14
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-03-14
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2021-03-09
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2010-09-08
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2007-03-28
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2025-07-01
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2022-11-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-03-28
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2010-09-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2010-09-08
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2017-12-06
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2012-08-24
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2022-08-17
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2021-03-03
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	1992-12-22

Official Correspondent

Chad Wade

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MICROAIRE SURGICAL INSTRUMENTS, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-04	Microaire Surgical Instruments	N/A	Wire Driver Coupler, Model 7100-045, a component of MicroAire Drill/Reamer Model 7500. Driver couplers are reuseable medical devices, non-sterile, packed one per box and labeled in part *MicroAire Surgical Instruments, 1641 Edlich Drive, Charlottesville, VA 22911*.
Z-0044-04	Microaire Surgical Instruments	N/A	Pin Driver Coupler, component of MicroAire Drill\Reamer Model 7500. Driver couplers are reuseable medical devices, non-sterile, packed one per box and labeled in part *MicroAire Surgical Instruments, 1641 Edlich Drive, Charlottesville, VA 22911*
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2020601. Last updated year: 2026. Please use registration number 2020601 when referencing this establishment in official correspondence.