FDA.reportPublic FDA data

T-Box®

Primary DI
M711LS2870
Brand
T-Box®
Company
INNO Holdings, Inc.
Model
LS-287
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
MQPSpinal Vertebral Body Replacement Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062151000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062151000BOX PEEK VBR SYSTEMInnovasis, Inc.2006-12-22MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711LS2870PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-10-11
00763000857950T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-10-11
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMQP2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19