FDA.reportPublic FDA data

Excella II®

Primary DI
M711LS1910
Brand
Excella II®
Company
INNO Holdings, Inc.
Model
LS-191
Catalog number
LS-191
Device description
SST
Published
2018-08-07
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
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711LS1910PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

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
DM exempt
true
Premarket exempt
true
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

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09348811172174INKAThe Trustee for KAISER FAMILY TRUSTHTX2025-11-21
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G586NS20266610Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286510Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286810Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS34214310Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G45333CC96MM900PEAK MEDPeak Medical Distribution Inc.HTX2023-03-07
07640178988750JULIET ® INSTRUMENTATIONSpineArt SAHTX2019-01-15
07640178988767JULIET ® INSTRUMENTATIONSpineArt SAHTX2019-01-15
07640185340602SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340787SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340794SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340800SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340817SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340824SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
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