FDA.reportPublic FDA data

Excella II®

Primary DI
M711LS0120
Brand
Excella II®
Company
INNO Holdings, Inc.
Model
LS-012
Catalog number
LS-012
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
HTCPliers, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTCPliers, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711LS0120PrimaryHIBCC0

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#

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M711511410120Endeavor™ Stand-Alone Cervical51-1410122026-05-31
M711511411070Endeavor™ Stand-Alone Cervical51-1411072026-05-31
M711511411120Endeavor™ Stand-Alone Cervical51-1411122026-05-31
M711511412070Endeavor™ Stand-Alone Cervical51-1412072026-05-31
M711511412120Endeavor™ Stand-Alone Cervical51-1412122026-05-31
M711511606070Endeavor™ Stand-Alone Cervical51-1606072026-05-31
M711511607070Endeavor™ Stand-Alone Cervical51-1607072026-05-31
M711511607120Endeavor™ Stand-Alone Cervical51-1607122026-05-31
M711511608070Endeavor™ Stand-Alone Cervical51-1608072026-05-31
M711511608120Endeavor™ Stand-Alone Cervical51-1608122026-05-31
M711511609070Endeavor™ Stand-Alone Cervical51-1609072026-05-31
M711511609120Endeavor™ Stand-Alone Cervical51-1609122026-05-31
M711511610070Endeavor™ Stand-Alone Cervical51-1610072026-05-31
M711511610120Endeavor™ Stand-Alone Cervical51-1610122026-05-31
M711511611070Endeavor™ Stand-Alone Cervical51-1611072026-05-31
M711511611120Endeavor™ Stand-Alone Cervical51-1611122026-05-31
M711511612070Endeavor™ Stand-Alone Cervical51-1612072026-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B8034605720ORTHOMEDORTHO-MED, INC.HTC2026-07-14
B8034605730ORTHOMEDORTHO-MED, INC.HTC2026-07-14
B8034605740ORTHOMEDORTHO-MED, INC.HTC2026-07-14
B8034709290ORTHOMEDORTHO-MED, INC.HTC2026-07-14
B8034802540ORTHOMEDORTHO-MED, INC.HTC2026-07-14
B8034802570ORTHOMEDORTHO-MED, INC.HTC2026-07-14
B8034802580ORTHOMEDORTHO-MED, INC.HTC2026-07-14
10887587077628NASynthes GmbHHTC2024-08-21
B356KJ666140American MedicalsAmerican MedicalsHTC2024-07-11
10840199539458ForcepKOROS U.S.A., INC.HTC2024-02-01
10840199539489ForcepKOROS U.S.A., INC.HTC2024-02-01
10840199535900ClampKOROS U.S.A., INC.HTC2024-01-31
10840199535962C ClampKOROS U.S.A., INC.HTC2024-01-31
10840199535993Aortic ClampKOROS U.S.A., INC.HTC2024-01-31
10840199536006Aortic ClampKOROS U.S.A., INC.HTC2024-01-31
00841435121621TecometTECOMET INC.HTC2023-07-20
B356KJ526120American MedicalsAmerican MedicalsHTC2022-12-14
14026704799135PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799142PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799159PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799166PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799319PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799326PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704811448PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
10840199539830ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539847ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539854ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539861ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539878ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539885ForcepsKOROS U.S.A., INC.HTC2022-10-31