Xpress MIS Pedicle Screw System

GUDID M697C07301030

SPECIAL ADJUSTMENT SCREWDRIVER ASSEMBLY

Xtant Medical Holdings, Inc.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device IDM697C07301030
NIH Device Record Keye2e6502d-0fae-4353-94ed-be22686677fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameXpress MIS Pedicle Screw System
Version Model NumberC073-0103
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Phone888-886-9354
EmailCS@xtantmedical.com
Phone888-886-9354
EmailCS@xtantmedical.com
Phone888-886-9354
EmailCS@xtantmedical.com
Phone888-886-9354
EmailCS@xtantmedical.com
Phone888-886-9354
EmailCS@xtantmedical.com
Phone888-886-9354
EmailCS@xtantmedical.com
Phone888-886-9354
EmailCS@xtantmedical.com
Phone888-886-9354
EmailCS@xtantmedical.com
Phone888-886-9354
EmailCS@xtantmedical.com
Phone888-886-9354
EmailCS@xtantmedical.com
Phone888-886-9354
EmailCS@xtantmedical.com
Phone888-886-9354
EmailCS@xtantmedical.com
Phone888-886-9354
EmailCS@xtantmedical.com
Phone888-886-9354
EmailCS@xtantmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697C07301030 [Direct Marking]
HIBCCM697C07301031 [Primary]

FDA Product Code

HXXScrewdriver

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697C07301030]

Moist Heat or Steam Sterilization

[M697C07301030]

Moist Heat or Steam Sterilization

[M697C07301030]

Moist Heat or Steam Sterilization

[M697C07301030]

Moist Heat or Steam Sterilization

[M697C07301030]

Moist Heat or Steam Sterilization

[M697C07301030]

Moist Heat or Steam Sterilization

[M697C07301030]

Moist Heat or Steam Sterilization

[M697C07301030]

Moist Heat or Steam Sterilization

[M697C07301030]

Moist Heat or Steam Sterilization

[M697C07301030]

Moist Heat or Steam Sterilization

[M697C07301030]

Moist Heat or Steam Sterilization

[M697C07301030]

Moist Heat or Steam Sterilization

[M697C07301030]

Moist Heat or Steam Sterilization

[M697C07301030]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-05
Device Publish Date2022-08-26

Devices Manufactured by Xtant Medical Holdings, Inc.

00840311247929 - Cortera Spinal Fixation System2024-05-03 CORTERA, 30° ANGLED DEROTATOR
00840311247912 - Cervalign2024-04-15 Cervalign, Rigid Screw Inserter, Sleeve
M697C02210000 - Fortex Pedicle Screw System2023-05-18 Special Adjustment Screwdriver Assembly Non-cannulated
M697C02200191 - Fortex Pedicle Screw System2023-04-06 4.75mm Special Single Lead Tap
M697C02200201 - Fortex Pedicle Screw System2023-04-06 5.5mm Special Single Lead Tap
M697C02200211 - Fortex Pedicle Screw System2023-04-06 6.5mm Special Single Lead Tap
M697C02200221 - Fortex Pedicle Screw System2023-04-06 7.5mm Special Single Lead Tap
M697C02200231 - Fortex Pedicle Screw System2023-04-06 8.25mm Special Single Lead Tap
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