FDA.reportPublic FDA data

Excella®-M

Primary DI
M711LA170010
Brand
Excella®-M
Company
INNO Holdings, Inc.
Model
LA-170-01
Device description
SST
Published
2022-03-31
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
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
M711LA170010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. 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
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M711620155550Vector™ Pedicle Screw System62-0155552026-09-30
M711620155600Vector™ Pedicle Screw System62-0155602026-09-30
M711620155650Vector™ Pedicle Screw System62-0155652026-09-30
M711620155700Vector™ Pedicle Screw System62-0155702026-09-30
M711620155750Vector™ Pedicle Screw System62-0155752026-09-30
M711620155800Vector™ Pedicle Screw System62-0155802026-09-30
M711620155850Vector™ Pedicle Screw System62-0155852026-09-30
M711620155900Vector™ Pedicle Screw System62-0155902026-09-30
M711620155950Vector™ Pedicle Screw System62-0155952026-09-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840916152413TALONSPINAL ELEMENTSMNH2020-04-14
00840916152420TALONSPINAL ELEMENTSMNH2020-04-14
00840916152437TALONSPINAL ELEMENTSMNH2020-04-14
00840916152444TALONSPINAL ELEMENTSMNH2020-04-14
00840916152529TALONSPINAL ELEMENTSMNH2020-04-14
00840916152536TALONSPINAL ELEMENTSMNH2020-04-14
00840916134013TALONSPINAL ELEMENTSMNI2019-03-26
00840916134020TALONSPINAL ELEMENTSMNI2019-03-26
00840916134037TALONSPINAL ELEMENTSMNI2019-03-26
00840916109837TALONSPINAL ELEMENTSMNH2017-07-10
00840916109844TALONSPINAL ELEMENTSMNH2017-07-10
00840916109851TALONSPINAL ELEMENTSMNH2017-07-10
00840916109868TALONSPINAL ELEMENTSMNH2017-07-10
00840916109875TALONSPINAL ELEMENTSMNH2017-07-10
00840916109882TALONSPINAL ELEMENTSMNH2017-07-10
00840916109899TALONSPINAL ELEMENTSMNH2017-07-10
00840916109905TALONSPINAL ELEMENTSMNH2017-07-10
00840916109912TALONSPINAL ELEMENTSMNH2017-07-10
00840916109929TALONSPINAL ELEMENTSMNH2017-07-10
00840916109950OMNISPINAL ELEMENTSMNH2017-07-10
00840916109967TALONSPINAL ELEMENTSMNH2017-07-10
00840916109974TALONSPINAL ELEMENTSMNH2017-07-10
00840916109981TALONSPINAL ELEMENTSMNH2017-07-10
00840916109998TALONSPINAL ELEMENTSMNH2017-07-10
00840916110000TALONSPINAL ELEMENTSMNH2017-07-10
00840916110017TALONSPINAL ELEMENTSMNH2017-07-10
00840916110024TALONSPINAL ELEMENTSMNH2017-07-10
00840916110055TALONSPINAL ELEMENTSMNH2017-07-10
00840916110062TALONSPINAL ELEMENTSMNH2017-07-10
00840916110079TALONSPINAL ELEMENTSMNH2017-07-10