FDA.reportPublic FDA data

Excella®-M

Primary DI
M711LS132010
Brand
Excella®-M
Company
INNO Holdings, Inc.
Model
LS-132-01
Catalog number
LS-132-01
Device description
Al, 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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042143000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042143000EXCELLA-M SPINAL SYSTEMInnovasis, Inc.2004-10-07KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711LS132010PrimaryHIBCC0

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
M711BTA2020Vector™ Pedicle Screw SystemBTA-2022026-06-05
M711LS7490Vector™ Pedicle Screw SystemLS-7492026-06-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
M719GL3110TiLockGenesys Orthopedics Systems LLCMNH2026-08-03
M719GL3110TiLockGenesys Orthopedics Systems LLCMNI2026-08-03
M719GLC403S0TiLockGenesys Orthopedics Systems LLCMNI2026-08-03
M719GLC403S0TiLockGenesys Orthopedics Systems LLCMNH2026-08-03
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-08-02
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-08-02
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-08-02
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-30
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-07-30
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-07-30
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-30