Zyfix Spinal Facet Screw System

GUDID M697X07600381

WASHER, Zygafix, 13mm

Xtant Medical Holdings, Inc.

Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile
Primary Device IDM697X07600381
NIH Device Record Keyff2d480d-29fb-4a58-83e0-4a347b835572
Commercial Distribution StatusIn Commercial Distribution
Brand NameZyfix Spinal Facet Screw System
Version Model NumberX076-0038
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

Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697X07600381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRWSYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697X07600381]

Moist Heat or Steam Sterilization

[M697X07600381]

Moist Heat or Steam Sterilization

[M697X07600381]

Moist Heat or Steam Sterilization

[M697X07600381]

Moist Heat or Steam Sterilization

[M697X07600381]

Moist Heat or Steam Sterilization

[M697X07600381]

Moist Heat or Steam Sterilization

[M697X07600381]

Moist Heat or Steam Sterilization

[M697X07600381]

Moist Heat or Steam Sterilization

[M697X07600381]

Moist Heat or Steam Sterilization

[M697X07600381]

Moist Heat or Steam Sterilization

[M697X07600381]

Moist Heat or Steam Sterilization

[M697X07600381]

Moist Heat or Steam Sterilization

[M697X07600381]

Moist Heat or Steam Sterilization

[M697X07600381]

Moist Heat or Steam Sterilization

[M697X07600381]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2021-06-03
Device Publish Date2015-08-28

On-Brand Devices [Zyfix Spinal Facet Screw System]

M697X07600381WASHER, Zygafix, 13mm
M697X07600371WASHER, Zygafix, 11mm
M697X07600341Zygafix COMPRESSION SCREW, 6.0 x 45MM SINGLE THREAD
M697X07600331Zygafix COMPRESSION SCREW, 6.0 x 40MM SINGLE THREAD
M697X07600321Zygafix COMPRESSION SCREW, 6.0 x 35MM SINGLE THREAD
M697X07600311Zygafix COMPRESSION SCREW, 6.0 x 30MM SINGLE THREAD
M697X07600301Zygafix COMPRESSION SCREW, 6.0 x 25MM SINGLE THREAD
M697X07600291Zygafix COMPRESSION SCREW, 6.0 x 20MM SINGLE THREAD
M697X07600241Zygafix COMPRESSION SCREW, 6.0 x 45MM DUAL THREAD
M697X07600231Zygafix COMPRESSION SCREW, 6.0 x 40MM DUAL THREAD
M697X07600221Zygafix COMPRESSION SCREW, 6.0 x 35MM DUAL THREAD
M697X07600211Zygafix COMPRESSION SCREW, 6.0 x 30MM DUAL THREAD
M697X07600201Zygafix COMPRESSION SCREW, 6.0 x 25MM DUAL THREAD
M697X07600040Implant Caddy, Zygafix
M697X07600030Sterilization Case, Zygafix
M697X06300870Blunt K-wire Holder
M697T07601160JAMSHIDI NEEDLE, 11G X 6"
M697T07601140.069 STYLET, 500mm
M697T07601130.069 STYLET, 300mm
M697T07601080.063 K-WIRE, 500mm, BLUNT
M697T07601070.063 K-WIRE, 350mm, BLUNT
M697T07601060.063 K-WIRE, 300mm, BLUNT
M697T07601050.063 K-WIRE, 250mm, BLUNT
M697T07601030.063 K-WIRE, 500mm, TROCAR
M697T07601020.063 K-WIRE, 350mm, TROCAR
M697T07601010.063 K-WIRE, 300mm, TROCAR
M697T07601000.063 K-WIRE, 250mm, TROCAR
M697T07600750LUER ADAPTER, FEMALE TO FEMALE
M697T07600660LUER SHAFT ASSY, SHORT
M697T07600650LUER SHAFT ASSY, LONG
M697T07600640SCREWDRIVER SHAFT ASSY, SHORT
M697T07600630SCREWDRIVER SHAFT ASSY, LONG
M697T07600590ACCESS SLEEVE ASSY, SHORT
M697T07600560BONE AWL, CANNULATED
M697T07600540GRAFT PACKER
M697T07600520OUTER DILATOR, 12mm, SHORT
M697T07600510OUTER DILATOR, 12mm, LONG
M697T07600500INNER DILATOR, 8mm
M697T076004602 FLUTE DRILL, NON-CANNULATED
M697T07600440TAP, CANNULATED
M697T076004304 FLUTE DRILL, CANNULATED
M697T076004030ACCESS SLEEVE, SHORT
M697T076004020ACCESS HEAD
M697T076004010ACCESS SLEEVE, LONG
M697T07600400ACCESS SLEEVE ASSY, LONG
M697C07600060Specialty Luer Lock adapter for Osteosponge putty syringe
M697C07600050Specialty Luer Lock adapter for Osteosponge putty syringe
M697C07600040Specialty Luer Lock adapter for Osteosponge putty syringe
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