Certex Spinal Fixation System

GUDID M697C06700510

SPECIAL INSTRUMENT CERTEX, SCREWDRIVER ASSEMBLY X067-0440 MODIFIED

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
Primary Device IDM697C06700510
NIH Device Record Key5d2dbfa5-e2fb-4f3f-86f5-79d0b4b5bb9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCertex Spinal Fixation System
Version Model NumberC067-0051
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697C06700510 [Direct Marking]
HIBCCM697C06700511 [Primary]

FDA Product Code

HXXScrewdriver

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697C06700510]

Moist Heat or Steam Sterilization

[M697C06700510]

Moist Heat or Steam Sterilization

[M697C06700510]

Moist Heat or Steam Sterilization

[M697C06700510]

Moist Heat or Steam Sterilization

[M697C06700510]

Moist Heat or Steam Sterilization

[M697C06700510]

Moist Heat or Steam Sterilization

[M697C06700510]

Moist Heat or Steam Sterilization

[M697C06700510]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-06
Device Publish Date2021-07-29

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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