FDA.reportPublic FDA data

C-Fuse® Cervical Intervertebral Body Fusion System

Primary DI
00815351021235
Brand
C-Fuse® Cervical Intervertebral Body Fusion System
Company
Southern Spine LLC
Model
C1412-6
Device description
Cervical Cage, 14mm X 12mm X 6mm
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K130948000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130948000C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEMSouthern Spine, LLC2013-08-14ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815351021235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815351021235008153510212358153510212350815351021235

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric 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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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 included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(478)330-6205donna@t3med.com

Regulatory Flags#

DUNS number
794672225
Device count
1
DM exempt
false
Premarket exempt
false
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
00815351022225Deploy™ Expandable Interbody SystemD-0008282022-01-10
00815351022232Deploy™ Expandable Interbody SystemD-0009282022-01-10
00815351022249Deploy™ Expandable Interbody SystemD-0010282022-01-10
00815351022256Deploy™ Expandable Interbody SystemD-0011282022-01-10
00815351022263Deploy™ Expandable Interbody SystemD-0012282022-01-10
00815351022270Deploy™ Expandable Interbody SystemD-0013282022-01-10
00815351022287Deploy™ Expandable Interbody SystemD-0014282022-01-10
00815351022294Deploy™ Expandable Interbody SystemD-0015282022-01-10
00815351022300Deploy™ Expandable Interbody SystemD-0016282022-01-10
00815351022317Deploy™ Expandable Interbody SystemD-0017282022-01-10
00815351022324Deploy™ Expandable Interbody SystemD-0008322022-01-10
00815351022331Deploy™ Expandable Interbody SystemD-0009322022-01-10
00815351022348Deploy™ Expandable Interbody SystemD-0010322022-01-10
00815351022478Deploy™ Expandable Interbody SystemD-0815282022-01-10
00815351022485Deploy™ Expandable Interbody SystemD-0816282022-01-10
00815351022492Deploy™ Expandable Interbody SystemD-0817282022-01-10
00815351022508Deploy™ Expandable Interbody SystemD-0810322022-01-10
00815351022515Deploy™ Expandable Interbody SystemD-0811322022-01-10
00815351022522Deploy™ Expandable Interbody SystemD-0812322022-01-10
00815351022539Deploy™ Expandable Interbody SystemD-0813322022-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840283404245ClariVy™VY SPINE LLCODP2026-03-19
00840283404252ClariVy™VY SPINE LLCODP2026-03-19
00840283404269ClariVy™VY SPINE LLCODP2026-03-19
00840283404276ClariVy™VY SPINE LLCODP2026-03-19
00840283404283ClariVy™VY SPINE LLCODP2026-03-19
00840493416687LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00840493416694LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00840493416700LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
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00841193127538EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127545EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127552EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127569EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
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00841193127583EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127590EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
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00841193127613EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127620EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127637EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
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00841193127668EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127675EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
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