Xspan Laminoplasty Fixation System

GUDID M697X0850110F04SP1

10mm PLATE, LAMINOPLASTY, INLINE, with HOOK & FIN, 4mm THROAT, SPECIAL SLOT

Xtant Medical Holdings, Inc.

Spinal fixation plate, non-bioabsorbable

Primary Device ID	M697X0850110F04SP1
NIH Device Record Key	55361d70-10eb-4c46-a33b-a429236e0b5c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Xspan Laminoplasty Fixation System
Version Model Number	X085-0110-F04-SP
Company DUNS	081224143
Company Name	Xtant Medical Holdings, Inc.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
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
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 Dimensions

Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter
Depth	4 Millimeter
Length	10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697X0850110F04SP1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K160114

FDA Product Code

NQW	ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[M697X0850110F04SP1]

Radiation Sterilization

[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

Radiation Sterilization

[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

Radiation Sterilization

[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

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[M697X0850110F04SP1]

Radiation Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2021-06-03
Device Publish Date	2016-04-08

On-Brand Devices [Xspan Laminoplasty Fixation System]

M697X0853009STR1	SCREW, 3.0mm x 9mm LONG, SELF-DRILLING
M697X08530091	SCREW, 3.0mm x 9mm LONG, SELF-DRILLING
M697X0853008STR1	SCREW, 3.0mm x 8mm LONG, SELF-DRILLING
M697X08530081	SCREW, 3.0mm x 8mm LONG, SELF-DRILLING
M697X0853007STR1	SCREW, 3.0mm x 7mm LONG, SELF-DRILLING
M697X08530071	SCREW, 3.0mm x 7mm LONG, SELF-DRILLING
M697X0853006STR1	SCREW, 3.0mm x 6mm LONG, SELF-DRILLING
M697X08530061	SCREW, 3.0mm x 6mm LONG, SELF-DRILLING
M697X0853005STR1	SCREW, 3.0mm x 5mm LONG, SELF-DRILLING
M697X08530051	SCREW, 3.0mm x 5mm LONG, SELF-DRILLING
M697X0852609STR1	SCREW, 2.6mm x 9mm LONG, SELF-DRILLING
M697X08526091	SCREW, 2.6mm x 9mm LONG, SELF-DRILLING
M697X0852608STR1	SCREW, 2.6mm x 8mm LONG, SELF-DRILLING
M697X08526081	SCREW, 2.6mm x 8mm LONG, SELF-DRILLING
M697X0852607STR1	SCREW, 2.6mm x 7mm LONG, SELF-DRILLING
M697X08526071	SCREW, 2.6mm x 7mm LONG, SELF-DRILLING
M697X0852606STR1	SCREW, 2.6mm x 6mm LONG, SELF-DRILLING
M697X08526061	SCREW, 2.6mm x 6mm LONG, SELF-DRILLING
M697X0852605STR1	SCREW, 2.6mm x 5mm LONG, SELF-DRILLING
M697X08526051	SCREW, 2.6mm x 5mm LONG, SELF-DRILLING
M697X0850312H06RUSTR1	12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED
M697X0850312H06RU1	12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED
M697X0850312H06RSTR1	12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT
M697X0850312H06R1	12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT
M697X0850312H06LUSTR1	12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
M697X0850312H06LU1	12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
M697X0850312H06LSTR1	12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT
M697X0850312H06L1	12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT
M697X0850312H04RUSTR1	12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT, UNSLOTTED
M697X0850312H04RU1	12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT, UNSLOTTED
M697X0850312H04RSTR1	12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT
M697X0850312H04R1	12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT
M697X0850312H04LUSTR1	12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
M697X0850312H04LU1	12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
M697X0850312H04LSTR1	12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT
M697X0850312H04L1	12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT
M697X0850312F06RSTR1	12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 6mm THROAT
M697X0850312F06R1	12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 6mm THROAT
M697X0850312F06LSTR1	12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 6mm THROAT
M697X0850312F06L1	12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 6mm THROAT
M697X0850312F04RSTR1	12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 4mm THROAT
M697X0850312F04R1	12mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 4mm THROAT
M697X0850312F04LSTR1	12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 4mm THROAT
M697X0850312F04L1	12mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 4mm THROAT
M697X0850310H06RUSTR1	10mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED
M697X0850310H06RU1	10mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED
M697X0850310H06RSTR1	10mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT
M697X0850310H06R1	10mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT
M697X0850310H06LUSTR1	10mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
M697X0850310H06LU1	10mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED