FDA.reportPublic FDA data

Streamline® MIS Spinal Fixation System

Primary DI
00840311245642
Brand
Streamline® MIS Spinal Fixation System
Company
Xtant Medical Holdings, Inc.
Model
04-RDSETSCR-INS
Catalog number
04-RDSETSCR-INS
Device description
Streamline MIS Red. Set Screw Inserter
Published
2026-03-18
Public version status
Update
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
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468050412PreviousGS10
00840311245642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468050412008464680504128464680504120846468050412
00840311245642008403112456428403112456420840311245642

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
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
00840311245390Streamline® MIS Spinal Fixation System04-CANNTAP-4004-CANNTAP-402026-03-18
00840311245406Streamline® MIS Spinal Fixation System04-CANNTAP-4504-CANNTAP-452026-03-18
00840311245437Streamline® MIS Spinal Fixation System04-CANNTAP-7504-CANNTAP-752026-03-18
00840311245703Streamline® MIS Spinal Fixation System04-SEQDILATOR-104-SEQDILATOR-12026-03-18
00840311245710Streamline® MIS Spinal Fixation System04-SEQDILATOR-204-SEQDILATOR-22026-03-18
00840311245727Streamline® MIS Spinal Fixation System04-SEQDILATOR-304-SEQDILATOR-32026-03-18
00840311245734Streamline® MIS Spinal Fixation System04-SEQDILATOR-404-SEQDILATOR-42026-03-18
00840311245741Streamline® MIS Spinal Fixation System04-SETSCREWINS04-SETSCREWINS2026-03-18
00840311245925Streamline® MIS Spinal Fixation System05-CT-TUBE05-CT-TUBE2026-03-18
00840311245932Streamline MIS Spinal Fixation System05-DILATOR05-DILATOR2026-04-30
00840311245956Streamline® MIS Spinal Fixation System05-FINALDRIVER05-FINALDRIVER2026-03-18
00840311245963Streamline® MIS Spinal Fixation System05-FINALDRIVER205-FINALDRIVER22026-03-18
00840311246700Streamline® MIS Spinal Fixation System05-TAPSLEEVE05-TAPSLEEVE2026-03-18
00840311246755Streamline MIS Spinal Fixation System51-GW-500-BLUNT51-GW-500-BLUNT2026-04-30
00840311246762Streamline MIS Spinal Fixation System51-GW-500-BLUNT-SS51-GW-500-BLUNT-SS2026-04-30
00840311246779Streamline MIS Spinal Fixation System51-GW-500-BLUNT-TH51-GW-500-BLUNT-TH2026-04-30
00840311246786Streamline MIS Spinal Fixation System51-GW-500-SHARP51-GW-500-SHARP2026-04-30
00840311246793Streamline MIS Spinal Fixation System51-GW-500-SHARP-SS51-GW-500-SHARP-SS2026-04-30
00840311246809Streamline MIS Spinal Fixation System51-GW-500-SHARP-TH51-GW-500-SHARP-TH2026-04-30
00840311246816Streamline MIS Spinal Fixation System51-GW-550-BLUNT51-GW-550-BLUNT2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800308486047INNOVERSE SPINAL SYSTEMCG MedTech Co.,Ltd.HXX2026-11-04
08800308486054INNOVERSE SPINAL SYSTEMCG MedTech Co.,Ltd.HXX2026-11-04
00841731133717REDEMPTION Beaming SystemVILEX LLCHXX2026-11-03
00841731133724REDEMPTION Beaming SystemVILEX LLCHXX2026-11-03
08800322759233Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08800322759240Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08809695602887Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08809974815953Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08809974816004Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
B382SD91449311010Surgical DirectSurgical Direct, Inc.HXX2026-10-28
08800089487820Surgical InstrumentJeil Medical CorporationHXX2026-10-26
00190776436933MillenniumAvalign Technologies, Inc.HXX2026-10-23
09120125220242Shark Screw® driver cutsurgebright GmbHHXX2026-10-22
00199150076451Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080373Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080380Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080397Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00824846013600Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HXX2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HXX2026-10-19
M697X06402401Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.HXX2026-10-14
B382SD1455810020Surgical DirectSurgical Direct, Inc.HXX2026-09-29
B382SD1455810030Surgical DirectSurgical Direct, Inc.HXX2026-09-29
10886982345462VOLTSynthes GmbHHXX2026-09-25
00840606197342OmegaSPINAL ELEMENTS, INC.HXX2026-09-22
07640139343185BAGUERA C INSTRUMENTATIONSpineArt SAHXX2026-08-27
00843210143644Monaco Pedicle Screw SystemAltus Spine, LLCHXX2026-08-24
00199150083091Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-22
B095329646Hintermann SeriesDt Medtech, LLCHXX2026-08-21
00199150083459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-08