Xsert Lumbar Expandable Interbody System

GUDID M697X0921210245STR0

12mm-17mm x 10mm x 24mm x 5° PLIF ASSY (STERILE)

X-SPINE SYSTEMS, INC.

Metallic spinal interbody fusion cage

Primary Device ID	M697X0921210245STR0
NIH Device Record Key	ab3c8b50-4931-4939-961a-d5f6d53a320e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Xsert Lumbar Expandable Interbody System
Version Model Number	X092-121024-5-STR
Company DUNS	610042587
Company Name	X-SPINE SYSTEMS, INC.
Device Count	1
DM Exempt	false
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	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
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

Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0
Angle	5 degree
Length	24 Millimeter
Width	10 Millimeter
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697X0921210245STR0 [Direct Marking]
HIBCC	M697X0921210245STR1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K160959

FDA Product Code

MAX	Intervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

[M697X0921210245STR0]

Radiation Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2020-02-24
Device Publish Date	2017-04-01

On-Brand Devices [Xsert Lumbar Expandable Interbody System]

M697X092121032STR0	12mm-17mm x 10mm x 32mm PLIF ASSY (STERILE)
M697X0921210320	12mm-17mm x 10mm x 32mm PLIF ASSY
M697X092121026STR0	12mm-17mm x 10mm x 26mm PLIF ASSY (STERILE)
M697X0921210265STR0	12mm-17mm x 10mm x 26mm x 5° PLIF ASSY (STERILE)
M697X09212102650	12mm-17mm x 10mm x 26mm x 5° PLIF ASSY
M697X09212102610STR0	12mm-17mm x 10mm x 26mm x 10° PLIF ASSY (STERILE)
M697X092121026100	12mm-17mm x 10mm x 26mm x 10° PLIF ASSY
M697X0921210260	12mm-17mm x 10mm x 26mm PLIF ASSY
M697X092121024STR0	12mm-17mm x 10mm x 24mm PLIF ASSY (STERILE)
M697X0921210245STR0	12mm-17mm x 10mm x 24mm x 5° PLIF ASSY (STERILE)
M697X09212102450	12mm-17mm x 10mm x 24mm x 5° PLIF ASSY
M697X09212102410STR0	12mm-17mm x 10mm x 24mm x 10° PLIF ASSY (STERILE)
M697X092121024100	12mm-17mm x 10mm x 24mm x 10° PLIF ASSY
M697X0921210240	12mm-17mm x 10mm x 24mm PLIF ASSY
M697X092091032STR0	9mm-13mm x 10mm x 32mm PLIF ASSY (STERILE)
M697X0920910320	9mm-13mm x 10mm x 32mm PLIF ASSY
M697X092091026STR0	9mm-13mm x 10mm x 26mm PLIF ASSY (STERILE)
M697X0920910265STR0	9mm-13mm x 10mm x 26mm x 5° PLIF ASSY (STERILE)
M697X09209102650	9mm-13mm x 10mm x 26mm x 5° PLIF ASSY
M697X0920910260	9mm-13mm x 10mm x 26mm PLIF ASSY
M697X092091024STR0	9mm-13mm x 10mm x 24mm PLIF ASSY (STERILE)
M697X0920910245STR0	9mm-13mm x 10mm x 24mm x 5° PLIF ASSY (STERILE)
M697X09209102450	9mm-13mm x 10mm x 24mm x 5° PLIF ASSY
M697X0920910240	9mm-13mm x 10mm x24mm PLIF ASSY
M697X092071032STR0	7mm-10mm x 10mm x 32mm PLIF ASSY (Sterile)
M697X0920710320	7mm-10mm x 10mm x 32mm PLIF ASSY
M697X092071026STR0	7mm-10mm x 10mm 26mm PLIF ASSY (Sterile)
M697X0920710260	7mm-10mm x 10mm 26mm PLIF ASSY
M697X092071024STR0	7mm-10mm x 10mm x 24mm PLIF ASSY (Sterile)
M697X0920710240	7mm-10mm x 10mm x 24mm PLIF ASSY
M697X09200060	Xsert Posterior Disc Prep Sterilization Case
M697X09200050	Xsert Instrument Sterilization Case
M697X09200020	Xsert Posterior Disc Prep set
M697X09200010	Xsert Instrument Set
M697T09219000	SLAP HAMMER
M697T09218000	RE-ENGAGEMENT GUIDE
M697T09217000	TAMP
M697T09216000	TORRQUE LIMITING HANDLE
M697T09215000	FIXED HANDLE
M697T09214000	GRAFT PACKING BLOCK
M697T09211000	ELEVATOR
M697T092100070	ANGLED RING CURETTE
M697T092100060	LATERAL RIGHT CURETTE
M697T092100050	LATERAL LEFT CURETTE
M697T092100040	REVERSE ANGLED CURETTE
M697T092100030	ANGLED CURETTE
M697T092100020	DOWN PUSHING CURETTE
M697T092100010	STRAIGHT CURETTE
M697T092090020	CURVED OSTEOTOME
M697T092090010	STRAIGHT OSTEOTOME