FDA.reportPublic FDA data

Fortex Pedicle Screw System

Primary DI
M697C01000880
Brand
Fortex Pedicle Screw System
Company
X-SPINE SYSTEMS, INC.
Model
C010-0088
Device description
Special Instrument Straight Lenke Probe
Published
2021-04-30
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
HXBProbe
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697C01000880Direct MarkingHIBCC0
M697C01000881PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-888-886-9354CS@xtantmedical.com
+1(888)886-9354cs@xtantmedical.com

Regulatory Flags#

DUNS number
610042587
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
M697C07800240H-Graft Interspinous AllograftC078-00242021-05-19
M697C07902610Silex Sacroiliac Joint Fusion SystemC079-02612021-05-19
M697C07902620Silex Sacroiliac Joint Fusion SystemC079-02622021-05-19
M697C00300090Calix Spinal Implant SystemC003-00092016-08-30
M697C00300260Calix Spinal Implant SystemC003-00262018-01-10
M697C00300270Calix Spinal Implant SystemC003-00272018-01-10
M697C00300280Calix Spinal Implant SystemC003-00282018-01-10
M697C00300290Calix Spinal Implant SystemC003-00292018-01-10
M697C00300300Calix Spinal Implant SystemC003-00302018-01-10
M697C00300310Calix Spinal Implant SystemC003-00312018-01-10
M697C00300320Calix Spinal Implant SystemC003-00322018-01-10
M697C00300330Calix Spinal Implant SystemC003-00332018-01-10
M697C00300340Calix Spinal Implant SystemC003-00342017-05-05
M697C00300350Calix Spinal Implant SystemC003-00352017-05-05
M697C00300360Calix Spinal Implant SystemC003-00362017-05-05
M697C00300370Calix Spinal Implant SystemC003-00372017-05-05
M697C00300380Calix Spinal Implant SystemC003-00382017-05-05
M697C00300390Calix Spinal Implant SystemC003-00392017-05-05
M697C00300400Calix Spinal Implant SystemC003-00402017-05-05
M697C00300410Calix Spinal Implant SystemC003-00412017-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150080304Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXB2026-06-05
00840311244874Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244881Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244904Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244928Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244935Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244942Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245017Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245024Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245062Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245079Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245130Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245154Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245161Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245185Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245208Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245222Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245239Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245253Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245284Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245345Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245369Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245970Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246007Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246014Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246045Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246113Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246175Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246250Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311246267Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03