FDA.reportPublic FDA data

VELOFIX™ PEEK CERVICAL CAGE

Primary DI
08800015946162
Brand
VELOFIX™ PEEK CERVICAL CAGE
Company
CG MedTech Co.,Ltd.
Model
PE141405C
Published
2017-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K171749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171749000Velofix(tm) Interbody Fusion SystemU&I Corporation2017-07-13ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800015946162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800015946162088000159461628800015946162

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688811082
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800308479131ANAX OCT SPINAL SYSTEMOSS07702026-10-14
08800037575166ANAX™ 5.5 SPINAL SYSTEMSF09612026-09-04
08800037575173ANAX™ 5.5 SPINAL SYSTEMSF09622026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMSF09632026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMSF09602026-09-04
08800308479070ANAX™ 5.5 CT SPINAL SYSTEMCTS02202026-08-19
08800308479094ANAX™ 5.5 CT SPINAL SYSTEMCTS02402026-08-19
08800308479117ANAX™ 5.5 CT SPINAL SYSTEMCTS02602026-08-19
08800247359822UniSpace® TPLIF CageTU02902026-06-27
08800247359839UniSpace® TPLIF CageTU03002026-06-27
08800247359846UniSpace® TPLIF CageTU03102026-06-27
08800247359853UniSpace® TPLIF CageTU03202026-06-27
08800247359860UniSpace® TPLIF CageTU03302026-06-27
08800247359877UniSpace® TPLIF CageTU03402026-06-27
08800247359884UniSpace® TPLIF CageTU03502026-06-27
08800247359891UniSpace® TPLIF CageTU01702026-06-27
08800247359907UniSpace® TPLIF CageTU01802026-06-27
08800247359914UniSpace® TPLIF CageTU01902026-06-27
08800247359921UniSpace® TPLIF CageTU02002026-06-27
08800247359938UniSpace® TPLIF CageTU02102026-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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