FDA.reportPublic FDA data

Certex Spinal Fixation System

Primary DI
M697X06703981
Brand
Certex Spinal Fixation System
Company
Xtant Medical Holdings, Inc.
Model
X067-0398
Device description
3.5mm DIA X 170mm ROD
Published
2015-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122163000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122163000CERTEX SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.2012-10-31MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697X06703981PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length170Millimeter
Outer Diameter3.5Millimeter

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
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840311244928Streamline MIS Spinal Fixation System04-55-PR-15004-55-PR-1502026-06-03
00840311244935Streamline MIS Spinal Fixation System04-55-PR-16004-55-PR-1602026-06-03
00840311244942Streamline MIS Spinal Fixation System04-55-PR-17004-55-PR-1702026-06-03
00840311245017Streamline MIS Spinal Fixation System04-55-PR-5504-55-PR-552026-06-03
00840311245024Streamline MIS Spinal Fixation System04-55-PR-6004-55-PR-602026-06-03
00840311245062Streamline MIS Spinal Fixation System04-55-PR-8004-55-PR-802026-06-03
00840311245079Streamline MIS Spinal Fixation System04-55-PR-9004-55-PR-902026-06-03
00840311245130Streamline MIS Spinal Fixation System04-55-RR-15004-55-RR-1502026-06-03
00840311245154Streamline MIS Spinal Fixation System04-55-RR-17004-55-RR-1702026-06-03
00840311245161Streamline MIS Spinal Fixation System04-55-RR-18004-55-RR-1802026-06-03
00840311245185Streamline MIS Spinal Fixation System04-55-RR-20004-55-RR-2002026-06-03
00840311245208Streamline MIS Spinal Fixation System04-55-RR-22004-55-RR-2202026-06-03
00840311245222Streamline MIS Spinal Fixation System04-55-RR-24004-55-RR-2402026-06-03
00840311245239Streamline MIS Spinal Fixation System04-55-RR-25004-55-RR-2502026-06-03
00840311245253Streamline MIS Spinal Fixation System04-55-RR-3504-55-RR-352026-06-03
00840311245284Streamline MIS Spinal Fixation System04-55-RR-4504-55-RR-452026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157081515ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081522ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081539ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081546ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081553ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081560ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081577ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081584ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081591ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081607ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081614ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081621ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081638ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081645ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081652ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081669ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081676ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081683ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081690ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081706ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081713ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081720ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081737ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081744ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081751ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081768ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081775ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081782ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081799ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081805ZAVATION SCREWZavation LLCKWP2026-06-04