FDA.reportPublic FDA data

Silex Sacroiliac Joint Fusion System

Primary DI
M697C07902610
Brand
Silex Sacroiliac Joint Fusion System
Company
X-SPINE SYSTEMS, INC.
Model
C079-0261
Device description
Special Instrument 8mm x 25cm Tamp Assembly
Published
2021-05-19
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
HXGTamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697C07902610Direct MarkingHIBCC0
M697C07902611PrimaryHIBCC0

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
+1(888)886-9354CS@xtantmedical.com

Regulatory Flags#

DUNS number
610042587
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
M697C07800240H-Graft Interspinous AllograftC078-00242021-05-19
M697C07902620Silex Sacroiliac Joint Fusion SystemC079-02622021-05-19
M697C01000880Fortex Pedicle Screw SystemC010-00882021-04-30
M697C00300090Calix Spinal Implant SystemC003-00092016-08-30
M697C00300260Calix Spinal Implant SystemC003-00262018-01-10
M697C00300270Calix Spinal Implant SystemC003-00272018-01-10
M697C00300280Calix Spinal Implant SystemC003-00282018-01-10
M697C00300290Calix Spinal Implant SystemC003-00292018-01-10
M697C00300300Calix Spinal Implant SystemC003-00302018-01-10
M697C00300310Calix Spinal Implant SystemC003-00312018-01-10
M697C00300320Calix Spinal Implant SystemC003-00322018-01-10
M697C00300330Calix Spinal Implant SystemC003-00332018-01-10
M697C00300340Calix Spinal Implant SystemC003-00342017-05-05
M697C00300350Calix Spinal Implant SystemC003-00352017-05-05
M697C00300360Calix Spinal Implant SystemC003-00362017-05-05
M697C00300370Calix Spinal Implant SystemC003-00372017-05-05
M697C00300380Calix Spinal Implant SystemC003-00382017-05-05
M697C00300390Calix Spinal Implant SystemC003-00392017-05-05
M697C00300400Calix Spinal Implant SystemC003-00402017-05-05
M697C00300410Calix Spinal Implant SystemC003-00412017-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150076178Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXG2026-06-05
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAHXG2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAHXG2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAHXG2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAHXG2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAHXG2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAHXG2025-12-17
08800038029323SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039414SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039421SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039438SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039445SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039452SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039469SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039476SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
00841732142206GENERIC Surgical InstrumentsCTL Medical CorporationHXG2025-03-31
00841732166950GENERIC Surgical InstrumentsCTL Medical CorporationHXG2024-11-01
08800038058262SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058279SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058286SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058293SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058309SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25