Certex Spinal Fixation System

GUDID M697X0670398LM1

3.5mm DIA X 170mm ROD WITH LINE

Xtant Medical Holdings, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDM697X0670398LM1
NIH Device Record Keyf0ff602c-d0fe-44ff-aa7c-7b597117399f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCertex Spinal Fixation System
Version Model NumberX067-0398LM
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

Device Dimensions

Length170 Millimeter
Outer Diameter3.5 Millimeter
Length170 Millimeter
Outer Diameter3.5 Millimeter
Length170 Millimeter
Outer Diameter3.5 Millimeter
Length170 Millimeter
Outer Diameter3.5 Millimeter
Length170 Millimeter
Outer Diameter3.5 Millimeter
Length170 Millimeter
Outer Diameter3.5 Millimeter
Length170 Millimeter
Outer Diameter3.5 Millimeter
Length170 Millimeter
Outer Diameter3.5 Millimeter
Length170 Millimeter
Outer Diameter3.5 Millimeter
Length170 Millimeter
Outer Diameter3.5 Millimeter
Length170 Millimeter
Outer Diameter3.5 Millimeter
Length170 Millimeter
Outer Diameter3.5 Millimeter
Length170 Millimeter
Outer Diameter3.5 Millimeter
Length170 Millimeter
Outer Diameter3.5 Millimeter
Length170 Millimeter
Outer Diameter3.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697X0670398LM1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697X0670398LM1]

Moist Heat or Steam Sterilization

[M697X0670398LM1]

Moist Heat or Steam Sterilization

[M697X0670398LM1]

Moist Heat or Steam Sterilization

[M697X0670398LM1]

Moist Heat or Steam Sterilization

[M697X0670398LM1]

Moist Heat or Steam Sterilization

[M697X0670398LM1]

Moist Heat or Steam Sterilization

[M697X0670398LM1]

Moist Heat or Steam Sterilization

[M697X0670398LM1]

Moist Heat or Steam Sterilization

[M697X0670398LM1]

Moist Heat or Steam Sterilization

[M697X0670398LM1]

Moist Heat or Steam Sterilization

[M697X0670398LM1]

Moist Heat or Steam Sterilization

[M697X0670398LM1]

Moist Heat or Steam Sterilization

[M697X0670398LM1]

Moist Heat or Steam Sterilization

[M697X0670398LM1]

Moist Heat or Steam Sterilization

[M697X0670398LM1]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-06-03
Device Publish Date2015-09-17

On-Brand Devices [Certex Spinal Fixation System]

M697X06718101OCCIPITAL PLATE, IN-LINE
M697X06717211CERTEX 6.0mm OFFSET LEFT LAMINA HOOK
M697X06717201CERTEX 4.5mm OFFSET LEFT LAMINA HOOK
M697X06717111CERTEX 6.0mm OFFSET RIGHT LAMINA HOOK
M697X06717101CERTEX 4.5mm OFFSET RIGHT LAMINA HOOK
M697X06717011CERTEX 6.0mm INLINE LAMINA HOOK
M697X06717001CERTEX 4.5mm INLINE LAMINA HOOK
M697X06716971CERTEX 3.5mm Pre-Bent Rod, 500mm, SMALL RADIUS, 90°
M697X06716961CERTEX 3.5mm Pre-Bent Rod, 400mm, SMALL RADIUS, 90°
M697X06716951CERTEX 3.5mm Pre-Bent Rod, 300mm, SMALL RADIUS, 90°
M697X06716941CERTEX 3.5mm Pre-Bent Rod, 280mm, SMALL RADIUS, 90°
M697X06716931CERTEX 3.5mm Pre-Bent Rod, 260mm, SMALL RADIUS, 90°
M697X06716921CERTEX 3.5mm Pre-Bent Rod, 240mm, SMALL RADIUS, 90°
M697X06716911CERTEX 3.5mm Pre-Bent Rod, 220mm, SMALL RADIUS, 90°
M697X06716901CERTEX 3.5mm Pre-Bent Rod, 200mm, SMALL RADIUS, 90°
M697X06716891CERTEX 3.5mm Pre-Bent Rod, 180mm, SMALL RADIUS, 90°
M697X06716881CERTEX 3.5mm Pre-Bent Rod, 160mm, SMALL RADIUS, 90°
M697X06716871CERTEX 3.5mm Pre-Bent Rod, 140mm, SMALL RADIUS, 90°
M697X06716861CERTEX 3.5mm Pre-Bent Rod, 120mm, SMALL RADIUS, 90°
M697X06716851CERTEX 3.5mm Pre-Bent Rod, 100mm, SMALL RADIUS, 90°
M697X06716821CERTEX 3.5mm Pre-Bent Rod, 500mm, 90°
M697X06716811CERTEX 3.5mm Pre-Bent Rod, 400mm, 90°
M697X06716801CERTEX 3.5mm Pre-Bent Rod, 300mm, 90°
M697X06716791CERTEX 3.5mm Pre-Bent Rod, 280mm, 90°
M697X06716781CERTEX 3.5mm Pre-Bent Rod, 260mm, 90°
M697X06716771CERTEX 3.5mm Pre-Bent Rod, 240mm, 90°
M697X06716761CERTEX 3.5mm Pre-Bent Rod, 220mm, 90°
M697X06716751CERTEX 3.5mm Pre-Bent Rod, 200mm, 90°
M697X06716741CERTEX 3.5mm Pre-Bent Rod, 180mm, 90°
M697X06716731CERTEX 3.5mm Pre-Bent Rod, 160mm, 90°
M697X06716721CERTEX 3.5mm Pre-Bent Rod, 140mm, 90°
M697X06716711CERTEX 3.5mm Pre-Bent Rod, 120mm, 90°
M697X06716701CERTEX 3.5mm Pre-Bent Rod, 100mm, 90°
M697X06716621CERTEX 3.5mm Pre-Bent Rod, 500mm, SMALL RADIUS, 67°
M697X06716611CERTEX 3.5mm Pre-Bent Rod, 400mm, SMALL RADIUS, 67°
M697X06716601CERTEX 3.5mm Pre-Bent Rod, 300mm, SMALL RADIUS, 67°
M697X06716591CERTEX 3.5mm Pre-Bent Rod, 280mm, SMALL RADIUS, 67°
M697X06716581CERTEX 3.5mm Pre-Bent Rod, 260mm, SMALL RADIUS, 67°
M697X06716571CERTEX 3.5mm Pre-Bent Rod, 240mm, SMALL RADIUS, 67°
M697X06716561CERTEX 3.5mm Pre-Bent Rod, 220mm, SMALL RADIUS, 67°
M697X06716551CERTEX 3.5mm Pre-Bent Rod, 200mm, SMALL RADIUS, 67°
M697X06716541CERTEX 3.5mm Pre-Bent Rod, 180mm, SMALL RADIUS, 67°
M697X06716531CERTEX 3.5mm Pre-Bent Rod, 160mm, SMALL RADIUS, 67°
M697X06716521CERTEX 3.5mm Pre-Bent Rod, 140mm, SMALL RADIUS, 67°
M697X06716511CERTEX 3.5mm Pre-Bent Rod, 120mm, SMALL RADIUS, 67°
M697X06716501CERTEX 3.5mm Pre-Bent Rod, 100mm, SMALL RADIUS, 67°
M697X0671637LM13.5mm DIA X 500mm CONTINUOUS RADIUS ROD WITH LINE
M697X067163713.5mm Continuous Radius Rod, 500mm
M697X0671636LM13.5mm DIA X 400mm CONTINUOUS RADIUS ROD WITH LINE
M697X067163613.5mm Continuous Radius Rod, 400mm
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