FDA.reportPublic FDA data

Px®

Primary DI
M711BTA920
Brand
Px®
Company
INNO Holdings, Inc.
Model
BTA-92
Device description
Implant Caddy, Px, 10mm x 25mm, 5°, Polypropylene, Radel, SST
Published
2025-02-28
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
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711BTA920PrimaryHIBCC0

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
Premarket 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
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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
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10198956408401CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956439726CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956442450CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956448308CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956448483CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956458291CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956461512CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
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10198956481367CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956484269CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956487314CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
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10198956504424CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956504776CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956504806CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956505490CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956505704CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956506909CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956507685CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956508019CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956508170CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956509382CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956509603CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956510418CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16