FDA.reportPublic FDA data

Irix-A Lumbar Integrated Fusion System

Primary DI
M697C08000730
Brand
Irix-A Lumbar Integrated Fusion System
Company
Xtant Medical Holdings, Inc.
Model
C080-0073
Device description
SPECIALTY IRIX A FIXED ANGLE DRIVER ASSEMBLY
Published
2016-08-30
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
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697C08000730Direct MarkingHIBCC0
M697C08000731PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(937)847-8400orders@x-spine.com
+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
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
00840311244904Streamline MIS Spinal Fixation System04-55-PR-13004-55-PR-1302026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150081882Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-10
00199150081899Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-10
00842188132513Tools - ScrewsTrimed, INC.HXX2026-07-09
00842188132520Tools - ScrewsTrimed, INC.HXX2026-07-09
06974940307878endophixSuzhou Endophix Co., Ltd.HXX2026-06-23
008401944961003P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944963773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944966433P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944969193P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
00889024707726SolidLok®Biomet Orthopedics, LLCHXX2026-06-10
08800322708224Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08800322758175Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08800322758267Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08800322758274Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
04719879398700Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-11-26
04719962169132Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-10-31
04719962169224Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-10-31
04719879398052Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-08-22
04719879398069Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-08-22
04719879398113Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-08-22
04719879398199Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-08-22
04719879398229Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-08-22
04719879398328Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-08-22
04719879398045Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-05-07
00841732135024MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2025-03-31
00841732141049MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2025-03-31
00841732142213MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2025-03-31
00841732142220MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2025-03-31
00841732142237MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2025-03-31
00841732142244MONDRIAN ALIF Cage with Supplementary Fixation PlateCTL Medical CorporationOVD2025-03-31