Silex Sacroiliac Joint Fusion System

GUDID M697C07902610

Special Instrument 8mm x 25cm Tamp Assembly

X-SPINE SYSTEMS, INC.

Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Primary Device IDM697C07902610
NIH Device Record Keyb19f5bf7-f31f-456e-b656-a1620e6886a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilex Sacroiliac Joint Fusion System
Version Model NumberC079-0261
Company DUNS610042587
Company NameX-SPINE SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697C07902610 [Direct Marking]
HIBCCM697C07902611 [Primary]

FDA Product Code

HXGTamp

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

[M697C07902610]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-27
Device Publish Date2021-05-19

On-Brand Devices [Silex Sacroiliac Joint Fusion System]

M697C07902620Special Instrument 8mm x 25cm Bone Funnel Assembly
M697C07902610Special Instrument 8mm x 25cm Tamp Assembly
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