FDA.reportPublic FDA data

Streamline® MIS Spinal Fixation System

Primary DI
00840311264872
Brand
Streamline® MIS Spinal Fixation System
Company
Xtant Medical Holdings, Inc.
Model
432-622
Catalog number
432-622
Device description
STREAMLINE MIS, INSTRUMENT TRAY 3
Published
2026-11-02
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRPTray, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840311264872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311264872008403112648728403112648720840311264872

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
00840311264858Streamline® MIS Spinal Fixation System432-620432-6202026-11-02
00840311264865Streamline® MIS Spinal Fixation System432-621432-6212026-11-02
00840311264889Streamline® MIS Spinal Fixation System432-623432-6232026-11-02
00840311264896Streamline® MIS Spinal Fixation System432-626432-6262026-11-02
00840311264902Streamline® MIS Spinal Fixation System432-627432-6272026-11-02
00840311264919Streamline® MIS Spinal Fixation System432-629432-6292026-11-02
00840311264926Streamline® MIS Spinal Fixation System432-630432-6302026-11-02
00840311264933Streamline® MIS Spinal Fixation System432-735432-7352026-11-02
00840311264940Streamline® MIS Spinal Fixation System432-736432-7362026-11-02
00840311264957Streamline® MIS Spinal Fixation System432-737432-7372026-11-02
00840311264964Streamline® MIS Spinal Fixation System432-738432-7382026-11-02
00840311264971Streamline® MIS Spinal Fixation System432-739432-7392026-11-02
00840311264988Streamline® MIS Spinal Fixation System432-740432-7402026-11-02
00840311264995Streamline® MIS Spinal Fixation System433-044433-0442026-11-02
00840311265015Streamline® MIS Spinal Fixation System433-902433-9022026-11-02
00840311265022Streamline® MIS Spinal Fixation System433-903433-9032026-11-02
00840311265039Streamline® MIS Spinal Fixation System433-904433-9042026-11-02
00840311265046Streamline® MIS Spinal Fixation System433-905433-9052026-11-02
00840311258185Fusion Lateral Instrument Set38-SLAPHAMMER2026-10-23
M697X06402401Xpress Minimally Invasive Pedicle Screw SystemX064-02402026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311264858Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264865Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264889Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264896Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264902Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264919Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264926Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264933Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264940Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264957Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264964Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264971Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264988Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264995Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311265015Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311265022Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311265039Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311265046Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00810017915194ALIF, Disc Prep Bottom LevelELEVATION SPINE, INC.LRP2026-10-30
00642356007298Mastel SurgicalMastel Surgical Inc.LRP2026-10-29
10198956566576CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956589612CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956593879CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956601550CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956608078CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956609037CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956620421CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956623255CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956623262CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956623279CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29