FDA.reportPublic FDA data

Latitude-C AM™ Cervical Interbody Fusion System

Primary DI
00842048183327
Brand
Latitude-C AM™ Cervical Interbody Fusion System
Company
DEGEN MEDICAL, INC.
Model
0306-121205L08
Catalog number
0306-121205L08
Device description
12W X 12D X 5H X 8° Latitude-C AM™ Cervical Spacer
Published
2025-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252737000DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical2025-10-10ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842048183327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842048183327008420481833278420481833270842048183327

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)240-7838customerservice@degenmedical.com

Regulatory Flags#

DUNS number
078812602
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842048154976Solar™ Interbody Fusion System12-28M12-28M2024-10-07
00842048182276DeGen Standard Instrumentation97-68M97-68M2025-03-10
00842048181910Solar™ Interbody Fusion System12-89M12-89M2024-06-10
00842048150343Solar™ Interbody Fusion System12-14M12-14M2023-07-15
00842048152996Latitude-C Cervical Interbody Spacer System03-03M03-03M2022-08-22
00842048137559Impulse Interbody Spacer System07-06M07-06M2021-12-22
00842048182726Latitude-C AM™ Cervical Interbody Fusion System0306-161405L040306-161405L042025-11-24
00842048182733Latitude-C AM™ Cervical Interbody Fusion System0306-161406L040306-161406L042025-11-24
00842048182740Latitude-C AM™ Cervical Interbody Fusion System0306-161407L040306-161407L042025-11-24
00842048182757Latitude-C AM™ Cervical Interbody Fusion System0306-161408L040306-161408L042025-11-24
00842048182764Latitude-C AM™ Cervical Interbody Fusion System0306-161409L040306-161409L042025-11-24
00842048182771Latitude-C AM™ Cervical Interbody Fusion System0306-161410L040306-161410L042025-11-24
00842048182788Latitude-C AM™ Cervical Interbody Fusion System0306-161411L040306-161411L042025-11-24
00842048182795Latitude-C AM™ Cervical Interbody Fusion System0306-161412L040306-161412L042025-11-24
00842048182801Latitude-C AM™ Cervical Interbody Fusion System0306-161413L040306-161413L042025-11-24
00842048182818Latitude-C AM™ Cervical Interbody Fusion System0306-161414L040306-161414L042025-11-24
00842048182979Latitude-C AM™ Cervical Interbody Fusion System0306-181410L040306-181410L042025-11-24
00842048182986Latitude-C AM™ Cervical Interbody Fusion System0306-181411L040306-181411L042025-11-24
00842048182993Latitude-C AM™ Cervical Interbody Fusion System0306-181412L040306-181412L042025-11-24
00842048183006Latitude-C AM™ Cervical Interbody Fusion System0306-181413L040306-181413L042025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017913763Saber-C Body (PT), 14x15x5 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913770Saber-C Body (PT), 14x15x6 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913787Saber-C Body (PT), 14x15x7 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913794Saber-C Body (PT), 14x15x8 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913800Saber-C Body (PT), 14x15x9 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913817Saber-C Body (PT), 14x15x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913824Saber-C Body (PT), 14x15x5 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913930Saber-C Body (PT), 14x17x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913947Saber-C Body (PT), 14x17x5 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913954Saber-C Body (PT), 14x17x6 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913961Saber-C Body (PT), 14x17x7 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913978Saber-C Body (PT), 14x17x8 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913985Saber-C Body (PT), 14x17x9 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913992Saber-C Body (PT), 14x17x10 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914005Saber-C Body (PT), 15x18x5 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914012Saber-C Body (PT), 15x18x6 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914029Saber-C Body (PT), 15x18x7 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914036Saber-C Body (PT), 15x18x8 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914043Saber-C Body (PT), 15x18x9 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914050Saber-C Body (PT), 15x18x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914425Saber-C Body (PT), 14x15x6 12 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914432Saber-C Body (PT), 14x15x7 12 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914449Saber-C Body (PT), 14x15x8 12 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914456Saber-C Body (PT), 14x15x9 12 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914463Saber-C Body (PT), 14x15x10 12 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017914654Saber-C Body (PT), 15x18x5 12 deg.ELEVATION SPINE, INC.ODP2026-10-26
B084AC1141605070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141606070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141607070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141608070Anterior Cervical IBFDKEOSODP2024-02-09