FDA.reportPublic FDA data

Cortera Spinal Fixation System

Primary DI
00840311253524
Brand
Cortera Spinal Fixation System
Company
Xtant Medical Holdings, Inc.
Model
150303-55600
Device description
CONNECTOR, R2R, OPEN-SIDE, 5.5-6.0, 11mm
Published
2025-08-21
Public version status
New
Distribution status
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241892000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241892000Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.2024-08-02NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840311253524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311253524008403112535248403112535240840311253524

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
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
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
00197157059521ZAVATION RODZavation LLCNKB2026-06-04
00197157059538ZAVATION RODZavation LLCNKB2026-06-04
00197157059545ZAVATION RODZavation LLCNKB2026-06-04
00197157059552ZAVATION RODZavation LLCNKB2026-06-04
00197157059569ZAVATION RODZavation LLCNKB2026-06-04
00197157059576ZAVATION RODZavation LLCNKB2026-06-04
00197157059583ZAVATION RODZavation LLCNKB2026-06-04
00197157059590ZAVATION RODZavation LLCNKB2026-06-04
00197157059606ZAVATION RODZavation LLCNKB2026-06-04
00197157059613ZAVATION RODZavation LLCNKB2026-06-04
00197157059620ZAVATION RODZavation LLCNKB2026-06-04
00197157059637ZAVATION RODZavation LLCNKB2026-06-04
00197157059644ZAVATION RODZavation LLCNKB2026-06-04
00197157059651ZAVATION RODZavation LLCNKB2026-06-04
00197157059668ZAVATION RODZavation LLCNKB2026-06-04
00197157059491ZAVATION RODZavation LLCNKB2026-06-03
00197157059507ZAVATION RODZavation LLCNKB2026-06-03
00197157059514ZAVATION RODZavation LLCNKB2026-06-03
00840311244874Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244881Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244904Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244928Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244935Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244942Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245017Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245024Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245062Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245079Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245130Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245154Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03