FDA.reportPublic FDA data

Zyfix Spinal Facet Screw System

Primary DI
M697T07600650
Brand
Zyfix Spinal Facet Screw System
Company
Xtant Medical Holdings, Inc.
Model
T076-0065
Device description
LUER SHAFT ASSY, LONG
Published
2015-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJGDEVICE, PERCUTANEOUS, BIOPSY
MRWSYSTEM, FACET SCREW SPINAL DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJGDevice, Percutaneous, BiopsyGeneral, Plastic Surgery1
MRWSystem, Facet Screw Spinal DeviceUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697T07600650Direct MarkingHIBCC0
M697T07600651PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(937)847-8400orders@x-spine.com
+1(888)886-9354cs@xtantmedical.com

Regulatory Flags#

DUNS number
081224143
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M697X07900081Silex Sacroiliac Joint Fusion SystemX079-00082026-07-08
M697X07900671Silex Sacroiliac Joint Fusion SystemX079-00672026-07-08
M697X07901121Silex Sacroiliac Joint Fusion SystemX079-01122026-07-08
M697X07901151Silex Sacroiliac Joint Fusion SystemX079-01152026-07-08
00849777014052Union DBM, 1cc11-0001-0012026-06-24
00849777014069Union DBM, 2.5cc11-0001-0022026-06-24
00849777014076Union DBM, 5cc11-0001-0052026-06-24
00849777014083Union DBM, 10cc11-0001-0102026-06-24
00810076560007BiomaXBMX-00012021-11-02
00810076560380BiomaXBMX-00022021-11-02
00810076560649BiomaXBMX-00052021-11-02
00810076560656BiomaXBMX-00102021-11-02
00810076560663BiomaXBMX-01012021-11-02
00810076560670BiomaXBMX-01022021-11-02
00810076560687BiomaXBMX-01052021-11-02
00810076560694BiomaXBMX-01102021-11-02
00840311263882Streamline OCT20-MODHANDLE20-MODHANDLE2026-06-04
00840311244874Streamline MIS Spinal Fixation System04-55-PR-10004-55-PR-1002026-06-03
00840311244881Streamline MIS Spinal Fixation System04-55-PR-11004-55-PR-1102026-06-03
00840311244904Streamline MIS Spinal Fixation System04-55-PR-13004-55-PR-1302026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131882761Facet Sterile Implant - 55Surgentec, LLCMRW2026-07-06
00810131882808Facet Sterile Instrument Kit - CervicalSurgentec, LLCMRW2026-07-06
00810131884772ION-C Final KitSurgentec, LLCMRW2026-07-06
00810131884895ION-C ReusableSurgentec, LLCMRW2026-07-06
10198956511699CARDINAL HEALTHCardinal Health 200, LLCMJG2026-07-06
08033860016883BIOPSYBELL SRLBIOPSYBELL SRLMJG2022-06-09
08056138586925FastCutEM.D.L. S.R.L.MJG2021-05-17
08056138586932FastCutSM.D.L. S.R.L.MJG2021-05-17
08056138584570Palium NeedleM.D.L. S.R.L.MJG2021-05-14
08056138584587Palium NeedleM.D.L. S.R.L.MJG2021-05-14
08056138584594Palium NeedleM.D.L. S.R.L.MJG2021-05-14
08056138584600Palium NeedleM.D.L. S.R.L.MJG2021-05-14
08056138584617Palium NeedleM.D.L. S.R.L.MJG2021-05-14
08056138584624Palium NeedleM.D.L. S.R.L.MJG2021-05-14
08056138584631Palium NeedleM.D.L. S.R.L.MJG2021-05-14
08056138584648Palium NeedleM.D.L. S.R.L.MJG2021-05-14
08056138584655Palium NeedleM.D.L. S.R.L.MJG2021-05-14
08056138584662Palium NeedleM.D.L. S.R.L.MJG2021-05-14
08056138584679Palium NeedleM.D.L. S.R.L.MJG2021-05-14
08056138584686Palium NeedleM.D.L. S.R.L.MJG2021-05-14
08056138584693FastCutPM.D.L. S.R.L.MJG2021-05-14
08056138584709FastCutPM.D.L. S.R.L.MJG2021-05-14
08056138584716FastCutPM.D.L. S.R.L.MJG2021-05-14
08056138584723FastCutPM.D.L. S.R.L.MJG2021-05-14
08056138584730FastCutPM.D.L. S.R.L.MJG2021-05-14
08056138584914EasyLockM.D.L. S.R.L.MJG2021-05-14
08056138584921EasyLockM.D.L. S.R.L.MJG2021-05-14
08056138586116HandCutM.D.L. S.R.L.MJG2021-05-14
08056138586123HandCutM.D.L. S.R.L.MJG2021-05-14
08056138586130HandCutM.D.L. S.R.L.MJG2021-05-14