FDA.reportPublic FDA data

Ti3D Cervical

Primary DI
00818345026780
Brand
Ti3D Cervical
Company
XENIX MEDICAL LLC
Model
B242-04
Device description
Ti3D C Cervical Trial, 14Wx12Dx4H, 6 deg
Published
2021-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K170318000
K222988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170318000NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC2017-07-12ODP
K222988000neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical2023-09-01ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818345026780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345026780008183450267808183450267800818345026780

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-594-8633cs@xenixmedical.com

Regulatory Flags#

DUNS number
080386764
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493424712RIVA Pedicle Screw SystemFG1-16-231600FG1-16-2316002026-07-13
00840493424729RIVA Pedicle Screw SystemFG1-15-240040FG1-15-2400402026-07-13
00840493424736RIVA Pedicle Screw SystemFG1-15-240045FG1-15-2400452026-07-13
00840493424743RIVA Pedicle Screw SystemFG1-15-240050FG1-15-2400502026-07-13
00840493424750RIVA Pedicle Screw SystemFG1-15-240055FG1-15-2400552026-07-13
00840493424767RIVA Pedicle Screw SystemFG1-15-240060FG1-15-2400602026-07-13
00840493424774RIVA Pedicle Screw SystemFG1-15-240065FG1-15-2400652026-07-13
00840493424781RIVA Pedicle Screw SystemFG1-15-240070FG1-15-2400702026-07-13
00840493424798RIVA Pedicle Screw SystemFG1-15-240075FG1-15-2400752026-07-13
00840493424804RIVA Pedicle Screw SystemFG1-15-240080FG1-15-2400802026-07-13
00840493424811RIVA Pedicle Screw SystemFG1-15-240085FG1-15-2400852026-07-13
00840493424828RIVA Pedicle Screw SystemFG1-15-240090FG1-15-2400902026-07-13
00840493424835RIVA Pedicle Screw SystemFG1-15-240095FG1-15-2400952026-07-13
00840493424842RIVA Pedicle Screw SystemFG1-15-240100FG1-15-2401002026-07-13
00840493424859RIVA Pedicle Screw SystemFG1-15-240110FG1-15-2401102026-07-13
00840493424866RIVA Pedicle Screw SystemFG1-15-240120FG1-15-2401202026-07-13
00840493424873RIVA Pedicle Screw SystemFG1-15-240130FG1-15-2401302026-07-13
00840493424880RIVA Pedicle Screw SystemFG1-15-240140FG1-15-2401402026-07-13
00840493424897RIVA Pedicle Screw SystemFG1-15-240150FG1-15-2401502026-07-13
00840493424903RIVA Pedicle Screw SystemFG1-15-240200FG1-15-2402002026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
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
00843511102326Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102333Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102340Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102357Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22