FDA.reportPublic FDA data

Silex Sacroiliac Joint Fusion System

Primary DI
M697C07902630
Brand
Silex Sacroiliac Joint Fusion System
Company
Xtant Medical Holdings, Inc.
Model
C079-0263
Device description
Special Guide Handle Assembly, Soft Tissue Shield
Published
2022-05-26
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140079000SILEX SACROILIAC JOINT FUSION SYSTEMX-Spine Systems, Inc.2014-03-25OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697C07902630Direct MarkingHIBCC0
M697C07902631PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implantation kitA collection of non-sterile 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
false
Premarket exempt
false
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
G079PDG2000Advantage-C Ti3D, Cervical InterbodyIntelivation, LLCFZX2026-07-10
M697X07901121Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.FZX2026-07-08
00190446948063Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948186Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948445Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948452Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
09421038412237KA Femoral Alignment GuideENZTEC LIMITEDFZX2026-06-24
09421038412244KA Femoral Alignment Guide - Medial PaddleENZTEC LIMITEDFZX2026-06-24
09421038412251KA Femoral Alignment Guide - Lateral PaddleENZTEC LIMITEDFZX2026-06-24
09421038412268KA Femoral Alignment Guide - FanENZTEC LIMITEDFZX2026-06-24
09421038412275KA Femoral Alignment Guide – IM GuideENZTEC LIMITEDFZX2026-06-24
09421038412282KA Femoral Alignment Guide – Pin Guide ConnectorENZTEC LIMITEDFZX2026-06-24
03700879518701NANOVASTEPFZX2026-06-23
03700879518718NANOVASTEPFZX2026-06-23
03700879518725NANOVASTEPFZX2026-06-23
03700879518732NANOVASTEPFZX2026-06-23
08800089483440Surgical InstrumentJeil Medical CorporationFZX2026-06-10
08800089483464Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2026-06-10
008401944960013P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944960183P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944962543P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944962613P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971763P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971833P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971903P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944972063P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
00889024701526Identity® Shoulder SystemZimmer, Inc.FZX2026-06-10
00889795154538Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10
00889795154545Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10
00889795154613Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10