FDA.reportPublic FDA data

Excella MIS®

Primary DI
M711LS3510
Brand
Excella MIS®
Company
INNO Holdings, Inc.
Model
LS-351
Catalog number
LS-351
Device description
Nitinol
Published
2019-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
M711LS3510PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length500Millimeter
Outer Diameter1.4Millimeter

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
Lot or batch
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
00197157122874ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122881ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122898ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122904ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122911ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122928ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122935ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122942ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122959ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122966ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122973ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122980ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122997ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123000ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123017ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123024ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123031ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123048ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123055ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123062ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123079ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123086ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123093ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123109ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123116ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123123ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123130ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123147ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123154ZAVATION SCREWZavation LLCNKB2026-10-20
00197157123161ZAVATION SCREWZavation LLCNKB2026-10-20