FDA.reportPublic FDA data

Certex Spinal Fixation System

Primary DI
M697X06700051
Brand
Certex Spinal Fixation System
Company
Xtant Medical Holdings, Inc.
Model
X067-0005
Device description
Polyaxial Screw Caddy, Certex
Published
2015-09-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKGPosterior cervical screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697X06700050Direct MarkingHIBCC0
M697X06700051PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)886-9354cs@xtantmedical.com

Regulatory Flags#

DUNS number
081224143
Device count
1
Lot or batch
true
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
07290117359549CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-07-13
07290117359563CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-07-13
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-28
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-06-27
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-27
10889981441555VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationKWP2026-06-24
00193982572983CREOGLOBUS MEDICAL, INC.KWP2026-06-10
04052536163403neon3Ulrich GmbH & Co. KGNKG2026-06-09
04052536163403neon3Ulrich GmbH & Co. KGKWP2026-06-09
04052536163410neon3Ulrich GmbH & Co. KGKWP2026-06-09
00887517656582ReLineNuvasive, Inc.KWP2026-04-15
00841732151024PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151031PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151048PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151055PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151062PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151079PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151086PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151093PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732149847TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-15
00841732149854TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-15
00841732150621TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-15
00841732163546PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732163553PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732163560PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732163577PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14