FDA.reportPublic FDA data

Excella® Navigation

Primary DI
M711LS6980
Brand
Excella® Navigation
Company
INNO Holdings, Inc.
Model
LS-698
Device description
Bone Tap, 8.0mm, Cannulated, MedT Nav, SST
Published
2024-03-31
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
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223511000Excella Navigation InstrumentsInnovasis, Inc.2023-05-02OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711LS6980PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter8Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
801-261-2236info@innovasis.com

Regulatory Flags#

DUNS number
141620464
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M711LB0720L-Box®LB-072LB-0722019-07-05
M711LB0730L-Box®LB-073LB-0732019-07-05
M711LB1340L-Box®LB-134LB-1342019-07-05
M711LB1350L-Box®LB-135LB-1352019-07-05
M711LS5530TruView™LS-5532022-03-31
M711511409070Endeavor™ Stand-Alone Cervical51-1409072026-05-01
M71151010Endeavor™ Stand-Alone Cervical51-012026-04-30
M711511406070Endeavor™ Stand-Alone Cervical51-1406072026-04-30
M711511407070Endeavor™ Stand-Alone Cervical51-1407072026-04-30
M711511407120Endeavor™ Stand-Alone Cervical51-1407122026-04-30
M711511408070Endeavor™ Stand-Alone Cervical51-1408072026-04-30
M711511408120Endeavor™ Stand-Alone Cervical51-1408122026-04-30
M711511409120Endeavor™ Stand-Alone Cervical51-1409122026-04-30
M711AXTI55350AxTiHA®AXTi5535AXTi55352026-03-31
M711AXTI55400AxTiHA®AXTi5540AXTi55402026-03-31
M711AXTI65350AxTiHA®AXTi6535AXTi65352026-03-31
M711AXTI65400AxTiHA®AXTi6540AXTi65402026-03-31
M711LS7980Navigation - Vector™ G-ELS-7982026-03-31
M711LA1120Excella®LA-1122024-01-31
M711LA1130Excella®LA-1132024-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862656117NewtonExactech, Inc.OLO2026-05-27
10885862656124NewtonExactech, Inc.OLO2026-05-27
10885862656131NewtonExactech, Inc.OLO2026-05-27
10885862656148NewtonExactech, Inc.OLO2026-05-27
10885862656155NewtonExactech, Inc.OLO2026-05-27
10885862656162NewtonExactech, Inc.OLO2026-05-27
10885862656179NewtonExactech, Inc.OLO2026-05-27
07613327594829Common Shoulder DriverMAKO SURGICAL CORP.OLO2026-05-21
07613327595543MakoMAKO SURGICAL CORP.OLO2026-05-21
07640221373021PERLA NAVSpineArt SAOLO2026-05-07
07640221373052PERLA NAVSpineArt SAOLO2026-05-07
07640221373069PERLA NAVSpineArt SAOLO2026-05-07
07640221373113PERLA NAVSpineArt SAOLO2026-05-07
07640221373120PERLA NAVSpineArt SAOLO2026-05-07
07640221373137PERLA NAVSpineArt SAOLO2026-05-07
07640221373144PERLA NAVSpineArt SAOLO2026-05-07
07640221373151PERLA NAVSpineArt SAOLO2026-05-07
07640221373168PERLA NAVSpineArt SAOLO2026-05-07
07640221373175PERLA NAVSpineArt SAOLO2026-05-07
07640221373182PERLA NAVSpineArt SAOLO2026-05-07
07640221373199PERLA NAVSpineArt SAOLO2026-05-07
07640221373205PERLA NAVSpineArt SAOLO2026-05-07
07640221373212PERLA NAVSpineArt SAOLO2026-05-07
07640221373229PERLA NAVSpineArt SAOLO2026-05-07
07640221373236PERLA NAVSpineArt SAOLO2026-05-07
07640221373243PERLA NAVSpineArt SAOLO2026-05-07
07640221373250PERLA NAVSpineArt SAOLO2026-05-07
07640221373267PERLA NAVSpineArt SAOLO2026-05-07
07640221373274PERLA NAVSpineArt SAOLO2026-05-07
07640221373281PERLA NAVSpineArt SAOLO2026-05-07