FDA.reportPublic FDA data

Silex Sacroiliac Joint Fusion System

Primary DI
M697C07900441
Brand
Silex Sacroiliac Joint Fusion System
Company
Xtant Medical Holdings, Inc.
Model
C079-0044
Device description
Specialty Silex Drill
Published
2017-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBIT, DRILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697C07900440Direct MarkingHIBCC0
M697C07900441PrimaryHIBCC0

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(937)847-8400orders@x-spine.com

Regulatory Flags#

DUNS number
081224143
Device count
1
Premarket exempt
true
Lot or batch
true
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
00190776395438MillenniumAvalign Technologies, Inc.HTW2026-07-13
00190446932406Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948216Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948483Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
09353903030218Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-06-24
00889795154507Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154514Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154521Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154606Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
08800089483433Drill bitJeil Medical CorporationHTW2026-06-10
08800089483457Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTW2026-06-10
04052536176700neon3Ulrich GmbH & Co. KGHTW2026-06-08
04052536176717neon3Ulrich GmbH & Co. KGHTW2026-06-08
00196449017355A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017362A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017409A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017416A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017423A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017430A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017447A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017461A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017478A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017485A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017492A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017508A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017515A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017522A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017539A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017546A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017560A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04