FDA.reportPublic FDA data

Fortress Pedicular Fixation

Primary DI
M7406410071
Brand
Fortress Pedicular Fixation
Company
SPINEOLOGY INC.
Model
55-03-20
Catalog number
641-0071
Device description
Screw Driver
Published
2024-01-10
Public version status
Update
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
M7406410071PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

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
Primary DIBrandModelCatalogPublished
M7401001373MIS TLIF System102-86-01100-13732026-05-21
M7401001371OptiLIF Endo, Direct Visualization System102-84-01100-13712026-04-06
M7406410015Fortress Pedicular Fixation64-02-01641-00152024-01-10
M7408610084Duo Expandable Interbody Fusion System86-11-51861-00842023-12-28
M7407408599Fortress Pedicale Screw10-10-57-45740-85992015-09-17
M7407404525Fortress Pedicale Screw10-10-57-1740-45252015-09-17
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
M7407405525Fortress Pedicale Screw10-10-57-7740-55252015-09-17
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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