FDA.reportPublic FDA data

MIS TLIF System

Primary DI
M7401001373
Brand
MIS TLIF System
Company
SPINEOLOGY INC.
Model
102-86-01
Catalog number
100-1373
Device description
Open TLIF Frame
Published
2026-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7401001373PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, manually-adjustedA manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
651-256-8500info@spineology.com

Regulatory Flags#

DUNS number
033014361
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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M7407404530Fortress Pedicale Screw10-10-57-2740-45302015-09-17
M7407404535Fortress Pedicale Screw10-10-57-3740-45352015-09-17
M7407404540Fortress Pedicale Screw10-10-57-4740-45402015-09-17
M7407404545Fortress Pedicale Screw10-10-57-5740-45452015-09-17
M7407404550Fortress Pedicale Screw10-10-57-6740-45502015-09-17
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M7407405530Fortress Pedicale Screw10-10-57-8740-55302015-09-17
M7407405535Fortress Pedicale Screw10-10-57-9740-55352015-09-17
M7407405540Fortress Pedicale Screw10-10-57-10740-55402015-09-17
M7407405545Fortress Pedicale Screw10-10-57-11740-55452015-09-17
M7407405550Fortress Pedicale Screw10-10-57-12740-55502015-09-17
M7407405555Fortress Pedicale Screw10-10-57-22740-55552015-09-17
M7407405560Fortress Pedicale Screw10-10-57-23740-55602015-09-17
M7407406525Fortress Pedicale Screw10-10-57-13740-65252015-09-17

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