FDA.reportPublic FDA data

Silex Sacroiliac Joint Fusion System

Primary DI
M697X07901151
Brand
Silex Sacroiliac Joint Fusion System
Company
Xtant Medical Holdings, Inc.
Model
X079-0115
Device description
Joint Decortication Instrument Assembly
Published
2026-07-08
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
HTZINSTRUMENT, CUTTING, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697X07901151PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implantation kitA collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. This is a reusable device.

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
true
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
00191083026664C-Plus PEEK IBF System724-729724-7292020-09-25
00840311211470Streamline TL Spinal Fixation System724-279724-2792026-07-30
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776407520MillenniumAvalign Technologies, Inc.HTZ2026-07-31
03701089527491AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527507AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527514AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527521AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527583AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527590AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527606AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527682AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527699AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527705AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527712AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527729AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527736AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527743AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527750AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527767AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527774AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527781AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527798AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527804AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527811AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527828AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527835AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527842AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527859AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089540780AMPLITUDEAMPLITUDE SASHTZ2026-07-29
00190776402129MillenniumAvalign Technologies, Inc.HTZ2026-07-19
10603295552390ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-05-18
07649988948701SPIRECUTSPIRECUT SAHTZ2026-05-04