FDA.reportPublic FDA data

CHENA-C PEEK Spacer System

Primary DI
B644CCS1513511100
Brand
CHENA-C PEEK Spacer System
Company
KAHTNU SURGICAL
Model
CCS1-5-13511-10
Device description
CHENA-C PEEK Spacer 5 Deg 13.5 x 11 x 10mm
Published
2018-12-31
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
K181140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181140000Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics2018-11-16ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B644CCS1513511100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesis, non-sterileA non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081208474
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B644KCP14780KASILOF Cervical Plate SystemKCP1-4782021-03-05
B644KCP14810KASILOF Cervical Plate SystemKCP1-4812021-03-05
B644KCP14840KASILOF Cervical Plate SystemKCP1-4842021-03-05
B644KCP14870KASILOF Cervical Plate SystemKCP1-4872021-03-05
B644KCP14900KASILOF Cervical Plate SystemKCP1-4902021-03-05
B644KCP150900KASILOF Cervical Plate SystemKCP1-50902021-03-05
B644KCP150950KASILOF Cervical Plate SystemKCP1-50952021-03-05
B644KCP151000KASILOF Cervical Plate SystemKCP1-51002021-03-05
B644KCP151050KASILOF Cervical Plate SystemKCP1-51052021-03-05
B644KCP151100KASILOF Cervical Plate SystemKCP1-51102021-03-05
B644KCP11190KASILOF Cervical Plate SystemKCP1-1192018-09-01
B644KCP11210KASILOF Cervical Plate SystemKCP1-1212018-09-01
B644KCP11230KASILOF Cervical Plate SystemKCP1-1232018-09-01
B644KCP11250KASILOF Cervical Plate SystemKCP1-1252018-09-01
B644KCP11270KASILOF Cervical Plate SystemKCP1-1272018-09-01
B644KCP11290KASILOF Cervical Plate SystemKCP1-1292018-09-01
B644KCP11310KASILOF Cervical Plate SystemKCP1-1312018-09-01
B644KCP11330KASILOF Cervical Plate SystemKCP1-1332018-09-01
B644KCP11350KASILOF Cervical Plate SystemKCP1-1352018-09-01
B644KCP12350KASILOF Cervical Plate SystemKCP1-2352018-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G079100120705S1Advantage C Cervical Interbody Fusion DeviceIntelivation, LLCODP2026-07-24
G079100140705S1Advantage C Cervical Interbody Fusion DeviceIntelivation, LLCODP2026-07-24
00810017914548Saber-C Body (PT), 14x17x6 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914562Saber-C Body (PT), 14x17x7 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00843511102579Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-07-23
00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102142Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
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00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102289Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102296Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102302Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102319Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
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00843511102333Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22