FDA.reportPublic FDA data

neoWave C

Primary DI
00818345028005
Brand
neoWave C
Company
XENIX MEDICAL LLC
Model
20-CFX-3207
Catalog number
N/A
Device description
neoWave C Cervical Cage, 13W x 12D x 7H, 14 deg
Published
2023-11-17
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
K222988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180401000TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC2018-06-14ODP
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
00818345028005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345028005008183450280058183450280050818345028005

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
00840493422398RIVA Pedicle Screw SystemFG1-16-200030FG1-16-2000302026-06-03
00840493422404RIVA Pedicle Screw SystemFG1-16-200035FG1-16-2000352026-06-03
00840493422411RIVA Pedicle Screw SystemFG1-16-200040FG1-16-2000402026-06-03
00840493422428RIVA Pedicle Screw SystemFG1-16-200045FG1-16-2000452026-06-03
00840493422435RIVA Pedicle Screw SystemFG1-16-200050FG1-16-2000502026-06-03
00840493422442RIVA Pedicle Screw SystemFG1-16-200055FG1-16-2000552026-06-03
00840493422459RIVA Pedicle Screw SystemFG1-16-200060FG1-16-2000602026-06-03
00840493422466RIVA Pedicle Screw SystemFG1-16-200065FG1-16-2000652026-06-03
00840493422473RIVA Pedicle Screw SystemFG1-16-200070FG1-16-2000702026-06-03
00840493422480RIVA Pedicle Screw SystemFG1-16-200075FG1-16-2000752026-06-03
00840493422497RIVA Pedicle Screw SystemFG1-16-200080FG1-16-2000802026-06-03
00840493422503RIVA Pedicle Screw SystemFG1-16-200085FG1-16-2000852026-06-03
00840493422510RIVA Pedicle Screw SystemFG1-16-200090FG1-16-2000902026-06-03
00840493422527RIVA Pedicle Screw SystemFG1-16-200095FG1-16-2000952026-06-03
00840493422534RIVA Pedicle Screw SystemFG1-16-200100FG1-16-2001002026-06-03
00840493422541RIVA Pedicle Screw SystemFG1-16-200110FG1-16-2001102026-06-03
00840493422558RIVA Pedicle Screw SystemFG1-16-200120FG1-16-2001202026-06-03
00840493422565RIVA Pedicle Screw SystemFG1-16-200130FG1-16-2001302026-06-03
00840493422572RIVA Pedicle Screw SystemFG1-16-200140FG1-16-2001402026-06-03
00840493422589RIVA Pedicle Screw SystemFG1-16-200150FG1-16-2001502026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986491008BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491015BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491022BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491039BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491046BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491053BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491060BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491077BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491084BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491091BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491107BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491114BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491121BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491138BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986490742BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490759BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490766BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490773BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490780BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490797BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490803BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490810BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490827BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490834BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490841BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490858BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490865BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490872BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490889BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490896BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03