FDA.reportPublic FDA data

Fortex Pedicle Screw System

Primary DI
M697X07704141
Brand
Fortex Pedicle Screw System
Company
Xtant Medical Holdings, Inc.
Model
X077-0414
Device description
CoCr, Straight Rods, 5.5mm Dia Bar X 120mm
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, spondylolisthesis spinal fixation
MNIOrthosis, spinal pedicle fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090224000
K120832000
K152132000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090224000FORTEX PEDICLE SCREW SYSTEMX-Spine Systems, Inc.2009-07-30MNH
K120832000FORTEX PEDICLE SCREW SYSTEMX-Spine Systems, Inc.2012-10-23MNH
K152132000X-spine Pedicle Screw SystemX-Spine Systems, Inc.2015-09-25MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697X07704141PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length120Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(937)847-8400orders@x-spine.com
+1(888)886-9354cs@xtantmedical.com

Regulatory Flags#

DUNS number
081224143
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840311263042Streamline TL Spinal Fixation System01-FX-55-5501-FX-55-552026-06-02
00840311263059Streamline TL Spinal Fixation System01-FX-55-6001-FX-55-602026-06-02
00840311263066Streamline TL Spinal Fixation System01-FX-65-6501-FX-65-652026-06-02
00840311263073Streamline TL Spinal Fixation System01-FX-65-7001-FX-65-702026-06-02
00840311263080Streamline TL Spinal Fixation System01-FX-65-7501-FX-65-752026-06-02
00840311263097Streamline TL Spinal Fixation System01-FX-65-8001-FX-65-802026-06-02
00840311263103Streamline TL Spinal Fixation System01-FX-65-8501-FX-65-852026-06-02
00840311263110Streamline TL Spinal Fixation System01-FX-65-9001-FX-65-902026-06-02
00840311263127Streamline TL Spinal Fixation System01-FX-65-9501-FX-65-952026-06-02
00840311263134Streamline TL Spinal Fixation System01-FX-65-10001-FX-65-1002026-06-02
00840311263141Streamline TL Spinal Fixation System01-FX-75-6501-FX-75-652026-06-02
00840311263158Streamline TL Spinal Fixation System01-FX-75-7001-FX-75-702026-06-02
00840311263165Streamline TL Spinal Fixation System01-FX-75-7501-FX-75-752026-06-02
00840311263172Streamline TL Spinal Fixation System01-FX-75-8001-FX-75-802026-06-02
00840311263189Streamline TL Spinal Fixation System01-FX-75-8501-FX-75-852026-06-02
00840311263196Streamline TL Spinal Fixation System01-FX-75-9001-FX-75-902026-06-02
00840311263202Streamline TL Spinal Fixation System01-FX-75-9501-FX-75-952026-06-02
00840311263219Streamline TL Spinal Fixation System01-FX-75-10001-FX-75-1002026-06-02
00840311263226Streamline TL Spinal Fixation System01-PA-115-7001-PA-115-702026-06-02
00840311263233Streamline TL Spinal Fixation System01-PA-115-8001-PA-115-802026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263080Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263080Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263097Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263097Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263103Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263103Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263110Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263110Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263127Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263127Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263134Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263134Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263141Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263141Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263158Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263158Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263165Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263165Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263172Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263172Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263189Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263189Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02