FDA.reportPublic FDA data

Vector™ Pedicle Screw System

Primary DI
M711BTA2020
Brand
Vector™ Pedicle Screw System
Company
INNO Holdings, Inc.
Model
BTA-202
Device description
Vector Instrument Set 1 - Al, SST, Nylon, Silicone, Radel
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711BTA2020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157119355ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119362ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119379ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119386ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119393ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119409ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119416ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119423ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119430ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119447ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119454ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119461ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119478ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119485ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119492ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119508ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119515ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119522ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119539ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119546ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119553ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119560ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119577ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119584ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119591ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119607ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119614ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119621ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119089ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119096ZAVATION SCREWZavation LLCNKB2026-10-05