FDA.reportPublic FDA data

Insurgical, Inc.

Primary DI
00860007230059
Brand
Insurgical, Inc.
Company
Insurgical, Inc.
Model
320-0107-001
Catalog number
9250023
Device description
3.2 - 4.0 Pin Driver Assembly
Published
2025-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GFCDriver, Surgical, Pin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFCDriver, Surgical, PinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007230059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007230059008600072300598600072300590860007230059

GMDN Terms#

Term, Definition table
TermDefinition
Pin-driving power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a wire driving/insertion function when an appropriate orthopaedic pin is inserted (e.g., K-Wire). It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078491571
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056900102Insurgical, Inc.320-0113-00280100012025-11-25
00850056900119Insurgical, Inc.320-0301-0023010001-R2025-11-25
00850056900126Insurgical, Inc.320-0302-0023010002-R2025-11-25
00850056900133Insurgical, Inc.320-0303-0023010003-R2025-11-25
00850056900140Insurgical, Inc.320-0201-00230100012025-11-25
00850056900157Insurgical, Inc.320-0202-00230100022025-11-25
00850056900164Insurgical, Inc.320-0203-00230100032025-11-25
00850056900089Insurgical, Inc.320-0110-00130030232025-01-17
00860007230004Insurgical, Inc.320-0064-00130100012025-01-17
00860007230028Insurgical, Inc.320-0071-00130100032025-01-17
00860007230035Insurgical, Inc.320-0067-00130100022025-01-17
00860007230042Insurgical, Inc.670-0003-00192500122025-01-17
00860007230066Insurgical, Inc.320-0070-00192500222025-01-17
00860007230073Insurgical, Inc.300-3002-00130030222025-01-17
00860007230080Insurgical, Inc.360-0001-00130040252025-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663108645Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCGFC2025-11-12
00842188130304K-WiresTrimed, INC.GFC2025-07-08
00841132197066PediNailORTHOPEDIATRICS CORP.GFC2025-06-05
00840194472401PNP FemurORTHOPEDIATRICS CORP.GFC2025-05-28
00840286842129Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286842136Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286846714Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855044Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855051Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855068Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855136Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855143Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855150Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855167Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286859950Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286843867UniSyn Hip SystemShalby Advanced Technologies, Inc.GFC2025-05-20
14053613292136PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292143PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292150PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292167PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613293164PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-15
04053613293167PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-15
00840286846707Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-14
04042409452987NAaap Implantate AGGFC2025-02-26
04042409453007NAaap Implantate AGGFC2025-02-26
04042409453021NAaap Implantate AGGFC2025-02-26
04042409453045NAaap Implantate AGGFC2025-02-26
00860007230066Insurgical, Inc.Insurgical, Inc.GFC2025-01-17
10886982347459NASynthes GmbHGFC2024-08-14
00840194478410Broken Screw Removal InstrumentsORTHOPEDIATRICS CORP.GFC2024-08-07