Xpress Minimally Invasive Pedicle Screw System

GUDID M697C01000760

Specialty Dual Lead Tap 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 Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	M697C01000760
NIH Device Record Key	c9220a96-c8f0-4f9c-84b2-01d87329b0ae
Commercial Distribution Status	In Commercial Distribution
Brand Name	Xpress Minimally Invasive Pedicle Screw System
Version Model Number	C010-0076
Company DUNS	081224143
Company Name	Xtant Medical Holdings, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com
Phone	+1(937)847-8400
Email	orders@x-spine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697C01000760 [Direct Marking]
HIBCC	M697C01000761 [Primary]

FDA Product Code

TAP, BONE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[M697C01000760]

Moist Heat or Steam Sterilization

[M697C01000760]

Moist Heat or Steam Sterilization

[M697C01000760]

Moist Heat or Steam Sterilization

[M697C01000760]

Moist Heat or Steam Sterilization

[M697C01000760]

Moist Heat or Steam Sterilization

[M697C01000760]

Moist Heat or Steam Sterilization

[M697C01000760]

Moist Heat or Steam Sterilization

[M697C01000760]

Moist Heat or Steam Sterilization

[M697C01000760]

Moist Heat or Steam Sterilization

[M697C01000760]

Moist Heat or Steam Sterilization

[M697C01000760]

Moist Heat or Steam Sterilization

[M697C01000760]

Moist Heat or Steam Sterilization

[M697C01000760]

Moist Heat or Steam Sterilization

[M697C01000760]

Moist Heat or Steam Sterilization

[M697C01000760]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2021-06-03
Device Publish Date	2016-11-01

On-Brand Devices [Xpress Minimally Invasive Pedicle Screw System]

M697X073825951	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 95mm
M697X073825901	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 90mm
M697X073825851	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 85mm
M697X073825801	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 80mm
M697X073825751	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 75mm
M697X073825701	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 70mm
M697X073825651	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 65mm
M697X073825601	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 60mm
M697X07382555DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 8.25 x 55mm
M697X073825551	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 55mm
M697X07382550DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 8.25 x 50mm
M697X073825501	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 50mm
M697X07382545DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 8.25 x 45mm
M697X073825451	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 45mm
M697X07382540DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 8.25 x 40mm
M697X073825401	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 40mm
M697X07382535DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 8.25 x 35mm
M697X073825351	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 35mm
M697X07382530DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 8.25 x 30mm
M697X073825301	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 30mm
M697X0738251001	XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 100mm
M697X0737595DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 95mm
M697X07375951	XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 95mm
M697X0737590DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 90mm
M697X07375901	XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 90mm
M697X0737585DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 85mm
M697X07375851	XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 85mm
M697X0737580DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 80mm
M697X07375801	XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 80mm
M697X0737575DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 75mm
M697X07375751	XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 75mm
M697X0737570DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 70mm
M697X07375701	XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 70mm
M697X0737565DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 65mm
M697X07375651	XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 65mm
M697X0737560DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 60mm
M697X07375601	XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 60mm
M697X0737555DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 55mm
M697X07375551	XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 55mm
M697X0737550DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 50mm
M697X07375501	XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 50mm
M697X0737545DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 45mm
M697X07375451	XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 45mm
M697X0737540DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 40mm
M697X07375401	XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 40mm
M697X0737535DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 35mm
M697X07375351	XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 35mm
M697X0737530DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 30mm
M697X07375301	XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 30mm
M697X07375100DL1	XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 100mm

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