FDA.reportPublic FDA data

Streamline TL Spinal Fixation System

Primary DI
00840311248421
Brand
Streamline TL Spinal Fixation System
Company
Xtant Medical Holdings, Inc.
Model
01-PA-105-60
Catalog number
01-PA-105-60
Device description
STREAMLINE TL, Ø10.5mm DOUBLE LEAD PEDICLE SCREW ASSEMBLY, 60mm
Published
2026-06-03
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
00191083020723PreviousGS10
00840311248421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191083020723001910830207231910830207230191083020723
00840311248421008403112484218403112484210840311248421

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
00810076560007BiomaXBMX-00012021-11-02
00810076560380BiomaXBMX-00022021-11-02
00810076560649BiomaXBMX-00052021-11-02
00810076560656BiomaXBMX-00102021-11-02
00810076560663BiomaXBMX-01012021-11-02
00810076560670BiomaXBMX-01022021-11-02
00810076560687BiomaXBMX-01052021-11-02
00810076560694BiomaXBMX-01102021-11-02
00840311263882Streamline OCT20-MODHANDLE20-MODHANDLE2026-06-04
00840311244874Streamline MIS Spinal Fixation System04-55-PR-10004-55-PR-1002026-06-03
00840311244881Streamline MIS Spinal Fixation System04-55-PR-11004-55-PR-1102026-06-03
00840311244904Streamline MIS Spinal Fixation System04-55-PR-13004-55-PR-1302026-06-03
00840311244928Streamline MIS Spinal Fixation System04-55-PR-15004-55-PR-1502026-06-03
00840311244935Streamline MIS Spinal Fixation System04-55-PR-16004-55-PR-1602026-06-03
00840311244942Streamline MIS Spinal Fixation System04-55-PR-17004-55-PR-1702026-06-03
00840311245017Streamline MIS Spinal Fixation System04-55-PR-5504-55-PR-552026-06-03
00840311245024Streamline MIS Spinal Fixation System04-55-PR-6004-55-PR-602026-06-03
00840311245062Streamline MIS Spinal Fixation System04-55-PR-8004-55-PR-802026-06-03
00840311245079Streamline MIS Spinal Fixation System04-55-PR-9004-55-PR-902026-06-03
00840311245130Streamline MIS Spinal Fixation System04-55-RR-15004-55-RR-1502026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536163403neon3Ulrich GmbH & Co. KGKWP2026-06-09
04052536163410neon3Ulrich GmbH & Co. KGKWP2026-06-09
08800043949180N/ATDM Co., Ltd.KWQ2026-06-05
08800043965029N/ATDM Co., Ltd.KWQ2026-06-05
08800043965036N/ATDM Co., Ltd.KWQ2026-06-05
08800043965043N/ATDM Co., Ltd.KWQ2026-06-05
08800043965050N/ATDM Co., Ltd.KWQ2026-06-05
08800043965067N/ATDM Co., Ltd.KWQ2026-06-05
08800043965074N/ATDM Co., Ltd.KWQ2026-06-05
08800043965081N/ATDM Co., Ltd.KWQ2026-06-05
08800043965098N/ATDM Co., Ltd.KWQ2026-06-05
08800043965104N/ATDM Co., Ltd.KWQ2026-06-05
08800043965111N/ATDM Co., Ltd.KWQ2026-06-05
08800043965128N/ATDM Co., Ltd.KWQ2026-06-05
08800043965135N/ATDM Co., Ltd.KWQ2026-06-05
08800043965142N/ATDM Co., Ltd.KWQ2026-06-05
08800043965159N/ATDM Co., Ltd.KWQ2026-06-05
08800043965166N/ATDM Co., Ltd.KWQ2026-06-05
08800043965173N/ATDM Co., Ltd.KWQ2026-06-05
08800043965180N/ATDM Co., Ltd.KWQ2026-06-05
08800043965197N/ATDM Co., Ltd.KWQ2026-06-05
08800043965203N/ATDM Co., Ltd.KWQ2026-06-05
08800043965210N/ATDM Co., Ltd.KWQ2026-06-05
08800043965227N/ATDM Co., Ltd.KWQ2026-06-05
08800043965234N/ATDM Co., Ltd.KWQ2026-06-05
08800043965241N/ATDM Co., Ltd.KWQ2026-06-05
08800043965258N/ATDM Co., Ltd.KWQ2026-06-05
08800043965265N/ATDM Co., Ltd.KWQ2026-06-05
08800043965272N/ATDM Co., Ltd.KWQ2026-06-05
08800043965289N/ATDM Co., Ltd.KWQ2026-06-05