FDA.reportPublic FDA data

IntelliSense Drill Technology

Primary DI
B666MOI30700020
Brand
IntelliSense Drill Technology
Company
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
Model
1.0
Catalog number
MOI3070002
Device description
IntelliSense Controller and Power Cord
Published
2022-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143191000IntelliSense DrillMcginley Innovations2015-02-20HWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B666MOI30700020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone/joint surgical power tool motorized handpiece/set, electric, reusableAn electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a non-dental surgical procedure. It includes an electric motor and one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3073156403support@mcginleyinnovations.com

Regulatory Flags#

DUNS number
078568266
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B666MCGLD2F0Lever Action Plate System0MCG-LD2F2025-09-23
B666MCGRD2F0Lever Action Plate System0MCG-RD2F2025-09-23
B666MCGLA1F0Lever Action Plate System0MCG-LA1F2020-11-16
B666MCGLA2V0Lever Action Plate System0MCG-LA2V2020-11-16
B666MCGLB1F0Lever Action Plate System0MCG-LB1F2020-11-16
B666MCGLB2V0Lever Action Plate System0MCG-LB2V2020-11-16
B666MCGLC1F0Lever Action Plate System0MCG-LC1F2020-11-16
B666MCGLC2V0Lever Action Plate System0MCG-LC2V2020-11-16
B666MCGLD1F0Lever Action Plate System0MCG-LD1F2020-11-16
B666MCGLD2V0Lever Action Plate System0MCG-LD2V2020-11-16
B666MCGLE1F0Lever Action Plate System0MCG-LE1F2020-11-16
B666MCGLE2V0Lever Action Plate System 0MCG-LE2V2020-11-16
B666MCGLF1F0Lever Action Plate System0MCG-LF1F2020-11-16
B666MCGLF2V0Lever Action Plate System0MCG-LF2V2020-11-16
B666MCGRA1F0Lever Action Plate System0MCG-RA1F2020-11-16
B666MCGRA2V0Lever Action Plate System0MCG-RA2V2020-11-16
B666MCGRB1F0Lever Action Plate System0MCG-RB1F2020-11-16
B666MCGRB2V0Lever Action Plate System0MCG-RB2V2020-11-16
B666MCGRC1F0Lever Action Plate System0MCG-RC1F2020-11-16
B666MCGRC2V0Lever Action Plate System0MCG-RC2V2020-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05430003362112WAW SLIM HANDPIECEDevroye Instruments BelgiumGEY2026-09-21
05430003362242WAW CHARGING STATIONDevroye Instruments BelgiumGEY2026-09-21
05430003362259WAW Duo FUE SystemDevroye Instruments BelgiumGEY2026-09-21
05430003362280WAW SOFTWAREDevroye Instruments BelgiumGEY2026-09-21
00889024712300Z1 POSTERIOR HAMMR ADPTRZimmer, Inc.GEY2026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRZimmer, Inc.GEY2026-08-25
05051471225565De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-08-03
05051471225541De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-08-01
05051471223844De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-07-21
05051471223851De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-07-21
05051471223868De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-07-21
05051471219519De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-24
05051471223875De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-03
05051471223639De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-01
05051471221697De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471221703De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471221710De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
10817417021323AsepticoASEPTICO, INC.GEY2026-04-08
10817417021330AsepticoASEPTICO, INC.GEY2026-04-08
10845854013144ERGOConmed CorporationGEY2026-03-24
00193982678265VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678326VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678975VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678999VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679064VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679088VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679101VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679125VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679149VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679163VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27