Fortex Pedicle Screw System

GUDID M697C01000880

Special Instrument Straight Lenke Probe

X-SPINE SYSTEMS, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDM697C01000880
NIH Device Record Keyc11ceffd-ac2e-41ba-9f10-dd9753432f82
Commercial Distribution StatusIn Commercial Distribution
Brand NameFortex Pedicle Screw System
Version Model NumberC010-0088
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
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
HIBCCM697C01000880 [Direct Marking]
HIBCCM697C01000881 [Primary]

FDA Product Code

HXBProbe
MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

[M697C01000880]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-10
Device Publish Date2021-04-30

Devices Manufactured by X-SPINE SYSTEMS, INC.

00849777011563 - DBM Putty 1.0cc2021-05-27 1.0cc (Jar)
00849777011570 - DMB Putty 10.0cc2021-05-27 10.0cc (Jar)
00849777011587 - DBM Putty 1.0cc - Syringe2021-05-27 1.0cc (Syringe)
00849777011594 - DBM Putty 10.0cc - Syringe2021-05-27 10.0cc (Syringe)
00889795113238 - BEAST Injectable Putty2021-05-27 BEAST Injectable Putty, 1.0cc
00889795113245 - BEAST Injectable Putty2021-05-27 BEAST Injectable Putty, 2.5cc
00889795113252 - BEAST Injectable Putty2021-05-27 BEAST Injectable Putty, 5.0cc
00889795113269 - BEAST Injectable Putty2021-05-27 BEAST Injectable Putty, 10cc
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