Xspan Laminoplasty Fixation System

GUDID M697X0850106F06USTR1

6mm PLATE, LAMINOPLASTY, INLINE, with HOOK & FIN, 6mm THROAT, UNSLOTTED

Xtant Medical Holdings, Inc.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device IDM697X0850106F06USTR1
NIH Device Record Keyd3bffc5d-1abf-4500-8926-9111b84c2465
Commercial Distribution StatusIn Commercial Distribution
Brand NameXspan Laminoplasty Fixation System
Version Model NumberX085-0106-F06-U-STR
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

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

Device Dimensions

Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter
Depth6 Millimeter
Length6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697X0850106F06USTR1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQWORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


[M697X0850106F06USTR1]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-06-03
Device Publish Date2016-04-08

On-Brand Devices [Xspan Laminoplasty Fixation System]

M697X0853009STR1SCREW, 3.0mm x 9mm LONG, SELF-DRILLING
M697X08530091SCREW, 3.0mm x 9mm LONG, SELF-DRILLING
M697X0853008STR1SCREW, 3.0mm x 8mm LONG, SELF-DRILLING
M697X08530081SCREW, 3.0mm x 8mm LONG, SELF-DRILLING
M697X0853007STR1SCREW, 3.0mm x 7mm LONG, SELF-DRILLING
M697X08530071SCREW, 3.0mm x 7mm LONG, SELF-DRILLING
M697X0853006STR1SCREW, 3.0mm x 6mm LONG, SELF-DRILLING
M697X08530061SCREW, 3.0mm x 6mm LONG, SELF-DRILLING
M697X0853005STR1SCREW, 3.0mm x 5mm LONG, SELF-DRILLING
M697X08530051SCREW, 3.0mm x 5mm LONG, SELF-DRILLING
M697X0852609STR1SCREW, 2.6mm x 9mm LONG, SELF-DRILLING
M697X08526091SCREW, 2.6mm x 9mm LONG, SELF-DRILLING
M697X0852608STR1SCREW, 2.6mm x 8mm LONG, SELF-DRILLING
M697X08526081SCREW, 2.6mm x 8mm LONG, SELF-DRILLING
M697X0852607STR1SCREW, 2.6mm x 7mm LONG, SELF-DRILLING
M697X08526071SCREW, 2.6mm x 7mm LONG, SELF-DRILLING
M697X0852606STR1SCREW, 2.6mm x 6mm LONG, SELF-DRILLING
M697X08526061SCREW, 2.6mm x 6mm LONG, SELF-DRILLING
M697X0852605STR1SCREW, 2.6mm x 5mm LONG, SELF-DRILLING
M697X08526051SCREW, 2.6mm x 5mm LONG, SELF-DRILLING
M697X0850312H06RUSTR112mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED
M697X0850312H06RU112mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED
M697X0850312H06RSTR112mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT
M697X0850312H06R112mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT
M697X0850312H06LUSTR112mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
M697X0850312H06LU112mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
M697X0850312H06LSTR112mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT
M697X0850312H06L112mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT
M697X0850312H04RUSTR112mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT, UNSLOTTED
M697X0850312H04RU112mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT, UNSLOTTED
M697X0850312H04RSTR112mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT
M697X0850312H04R112mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT
M697X0850312H04LUSTR112mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
M697X0850312H04LU112mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
M697X0850312H04LSTR112mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT
M697X0850312H04L112mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT
M697X0850312F06RSTR112mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 6mm THROAT
M697X0850312F06R112mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 6mm THROAT
M697X0850312F06LSTR112mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 6mm THROAT
M697X0850312F06L112mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 6mm THROAT
M697X0850312F04RSTR112mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 4mm THROAT
M697X0850312F04R112mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK & FIN, 4mm THROAT
M697X0850312F04LSTR112mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 4mm THROAT
M697X0850312F04L112mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK & FIN, 4mm THROAT
M697X0850310H06RUSTR110mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED
M697X0850310H06RU110mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT, UNSLOTTED
M697X0850310H06RSTR110mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT
M697X0850310H06R110mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 6mm THROAT
M697X0850310H06LUSTR110mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED
M697X0850310H06LU110mm PLATE, LAMINOPLASTY, ANGLED LEFT, with HOOK, 4mm THROAT, UNSLOTTED

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.