FDA.reportPublic FDA data

Cortera Spinal Fixation System

Primary DI
00840311264032
Brand
Cortera Spinal Fixation System
Company
Xtant Medical Holdings, Inc.
Model
1509-130040
Catalog number
1509-130040
Device description
MIS Cap, Guidewire Caddy
Published
2026-07-20
Public version status
New
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
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840311264032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311264032008403112640328403112640320840311264032

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
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
00840311258635C-Plus PEEK IBF System724-729724-7292026-08-26
00191083026664C-Plus PEEK IBF System724-729724-7292020-09-25
00840311211470Streamline TL Spinal Fixation System724-279724-2792026-07-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816611026649AngioSystems TrayANGIOSYSTEMS, INCORPORATEDLRP2026-09-22
10198956446953CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956486294CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956520240CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956570191CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956578371CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956578401CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956579644CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956588042CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956588868CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956588875CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589070CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589148CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589155CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589483CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589636CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956590342CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956591561CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956592094CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956592834CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956592995CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956593312CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956593329CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594050CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594067CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594456CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594463CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594708CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956587861CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-21