FDA.reportPublic FDA data

Streamline® MIS Spinal Fixation System

Primary DI
00840311245925
Brand
Streamline® MIS Spinal Fixation System
Company
Xtant Medical Holdings, Inc.
Model
05-CT-TUBE
Catalog number
05-CT-TUBE
Device description
Streamline MIS, Counter-Torque Tube
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468050627PreviousGS10
00840311245925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468050627008464680506278464680506270846468050627
00840311245925008403112459258403112459250840311245925

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
00840311245642Streamline® MIS Spinal Fixation System04-RDSETSCR-INS04-RDSETSCR-INS2026-03-18
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
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
00810111228367ElevatorTreace Medical Concepts, Inc.LXH2026-11-05
08809986489814LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-11-05
08809986489821LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-11-05
08809986489838LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-11-05
08809986489845LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-11-05
08809986489852LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-11-05
08809986489869LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-11-05
08809986489876LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-11-05
08809986489883LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-11-05
08809986489890LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-11-05
08809986489906LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-11-05
00190776437855MillenniumAvalign Technologies, Inc.LXH2026-11-04
00190776437862MillenniumAvalign Technologies, Inc.LXH2026-11-04
00190776439873MilleniumAvalign Technologies, Inc.LXH2026-11-04
00810155330057Tigon MedicalTigon Medical LLCLXH2026-11-04
08800308486030INNOVERSE SPINAL SYSTEMCG MedTech Co.,Ltd.LXH2026-11-04
09353903030331OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030348OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030379OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030386OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030393OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030416OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
09353903030430OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDLXH2026-11-04
00841731133564REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133571REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133601REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133618REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133625REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133632REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03
00841731133649REDEMPTION Beaming SystemVILEX LLCLXH2026-11-03