FDA.reportPublic FDA data

Streamline TL Spinal Fixation System

Primary DI
00840311263202
Brand
Streamline TL Spinal Fixation System
Company
Xtant Medical Holdings, Inc.
Model
01-FX-75-95
Catalog number
01-FX-75-95
Device description
STREAMLINE TL, 7.5mm FIXED PEDICLE SCREW, 95mm
Published
2026-06-02
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAppliance, fixation, spinal intervertebral body
MNHOrthosis, spondylolisthesis spinal fixation
MNIOrthosis, spinal pedicle fixation
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191083020181PreviousGS10
00840311263202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191083020181001910830201811910830201810191083020181
00840311263202008403112632028403112632020840311263202

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
081224143
Device count
1
DM exempt
false
Premarket exempt
false
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
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
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
00840311263240Streamline TL Spinal Fixation System01-PA-115-9001-PA-115-902026-06-02

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