FDA.reportPublic FDA data

neoWave C

Primary DI
00818345027497
Brand
neoWave C
Company
XENIX MEDICAL LLC
Model
20-CFN-6412
Catalog number
N/A
Device description
neoWave C Cervical Cage, 16W x 14D x 12H, 0 deg
Published
2022-03-31
Public version status
Update
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
K180401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180401000TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC2018-06-14ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818345027497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345027497008183450274978183450274970818345027497

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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical 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 included with the device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080386764
Device count
1
Lot or batch
true
Expiration date on label
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
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
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