FDA.reportPublic FDA data

Streamline MIS Spinal Fixation System

Primary DI
00840311245192
Brand
Streamline MIS Spinal Fixation System
Company
Xtant Medical Holdings, Inc.
Model
04-55-RR-210
Catalog number
04-55-RR-210
Device description
MIS Straight Rod, Ø5.5mm X 210mm
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, spondylolisthesis spinal fixation
MNIOrthosis, spinal pedicle fixation
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192396000Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.2019-11-26NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191083019246PreviousGS10
00840311245192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191083019246001910830192461910830192460191083019246
00840311245192008403112451928403112451920840311245192

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840311264032Cortera Spinal Fixation System1509-1300401509-1300402026-07-20
M697X07900081Silex Sacroiliac Joint Fusion SystemX079-00082026-07-08
M697X07900671Silex Sacroiliac Joint Fusion SystemX079-00672026-07-08
M697X07901121Silex Sacroiliac Joint Fusion SystemX079-01122026-07-08
M697X07901151Silex Sacroiliac Joint Fusion SystemX079-01152026-07-08
00849777014052Union DBM, 1cc11-0001-0012026-06-24
00849777014069Union DBM, 2.5cc11-0001-0022026-06-24
00849777014076Union DBM, 5cc11-0001-0052026-06-24
00849777014083Union DBM, 10cc11-0001-0102026-06-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115932508Tower Guide STPREMIA SPINE LTDMNI2026-07-23
07290115932508Tower Guide STPREMIA SPINE LTDMNH2026-07-23
07290115932508Tower Guide STPREMIA SPINE LTDNKB2026-07-23
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCNKB2026-07-23
00840019935319Reform TiPRECISION SPINE, INC.NKB2019-10-07
00840019935364Reform TiPRECISION SPINE, INC.NKB2019-10-07
00840019934800Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934817Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934824Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934831Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934725Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934732Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934749Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934756Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934763Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934770Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934787Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934794Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934251Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934268Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934275Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934282Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934299Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934305Reform TIPRECISION SPINE, INC.NKB2019-09-10
00840019934312Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934329Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934336Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934343Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934350Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934367Reform TIPRECISION SPINE, INC.NKB2019-09-10