FDA.reportPublic FDA data

Excella II®

Primary DI
M711LS1290
Brand
Excella II®
Company
INNO Holdings, Inc.
Model
LS-129
Catalog number
LS-129
Device description
SST
Published
2018-01-31
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
KWPAppliance, Fixation, Spinal Interlaminal
KWQAppliance, Fixation, Spinal Intervertebral Body
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102248000EXCELLA II SPINAL SYSTEM MODEL EC2-00Innovasis, Inc.2010-10-07NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711LS1290PrimaryHIBCC0

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
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M711511410070Endeavor™ Stand-Alone Cervical51-1410072026-05-31
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
M711511612120Endeavor™ Stand-Alone Cervical51-1612122026-05-31
M711511806070Endeavor™ Stand-Alone Cervical51-1806072026-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157059262ZAVATION RODZavation LLCNKB2026-06-02
00197157059279ZAVATION RODZavation LLCNKB2026-06-02
00197157059286ZAVATION RODZavation LLCNKB2026-06-02
00197157059293ZAVATION RODZavation LLCNKB2026-06-02
00197157059309ZAVATION RODZavation LLCNKB2026-06-02
00197157059316ZAVATION RODZavation LLCNKB2026-06-02
00197157059323ZAVATION RODZavation LLCNKB2026-06-02
00197157059330ZAVATION RODZavation LLCNKB2026-06-02
00197157059347ZAVATION RODZavation LLCNKB2026-06-02
00197157059354ZAVATION RODZavation LLCNKB2026-06-02
00197157059361ZAVATION RODZavation LLCNKB2026-06-02
00197157059378ZAVATION RODZavation LLCNKB2026-06-02
00197157059385ZAVATION RODZavation LLCNKB2026-06-02
00197157059392ZAVATION RODZavation LLCNKB2026-06-02
00197157059408ZAVATION RODZavation LLCNKB2026-06-02
00197157059415ZAVATION RODZavation LLCNKB2026-06-02
00197157059422ZAVATION RODZavation LLCNKB2026-06-02
00197157059439ZAVATION RODZavation LLCNKB2026-06-02
00197157059446ZAVATION RODZavation LLCNKB2026-06-02
00197157059453ZAVATION RODZavation LLCNKB2026-06-02
00197157059460ZAVATION RODZavation LLCNKB2026-06-02
00197157059477ZAVATION RODZavation LLCNKB2026-06-02
00197157059484ZAVATION RODZavation LLCNKB2026-06-02
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWP2026-06-02
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-02
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWP2026-06-02