FDA.reportPublic FDA data

neoWave C

Primary DI
00840493415024
Brand
neoWave C
Company
XENIX MEDICAL LLC
Model
20-K01-0006
Catalog number
20-K01-0006
Device description
Rasp, Universal
Published
2025-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
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
00840493415024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493415024008404934150248404934150240840493415024

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493425559RIVA Pedicle Screw SystemFG1-15-300600FG1-15-3006002026-08-03
00840493425566RIVA Pedicle Screw SystemFG1-16-300025FG1-16-3000252026-08-03
00840493425573RIVA Pedicle Screw SystemFG1-16-300030FG1-16-3000302026-08-03
00840493425580RIVA Pedicle Screw SystemFG1-16-300035FG1-16-3000352026-08-03
00840493425597RIVA Pedicle Screw SystemFG1-16-300040FG1-16-3000402026-08-03
00840493425603RIVA Pedicle Screw SystemFG1-16-300045FG1-16-3000452026-08-03
00840493425610RIVA Pedicle Screw SystemFG1-16-300050FG1-16-3000502026-08-03
00840493425627RIVA Pedicle Screw SystemFG1-16-300055FG1-16-3000552026-08-03
00840493425634RIVA Pedicle Screw SystemFG1-16-300060FG1-16-3000602026-08-03
00840493425641RIVA Pedicle Screw SystemFG1-16-300065FG1-16-3000652026-08-03
00840493425658RIVA Pedicle Screw SystemFG1-16-300070FG1-16-3000702026-08-03
00840493425665RIVA Pedicle Screw SystemFG1-16-300075FG1-16-3000752026-08-03
00840493425672RIVA Pedicle Screw SystemFG1-16-300080FG1-16-3000802026-08-03
00840493425689RIVA Pedicle Screw SystemFG1-16-300085FG1-16-3000852026-08-03
00840493425696RIVA Pedicle Screw SystemFG1-16-300090FG1-16-3000902026-08-03
00840493425702RIVA Pedicle Screw SystemFG1-16-300095FG1-16-3000952026-08-03
00840493425719RIVA Pedicle Screw SystemFG1-16-300100FG1-16-3001002026-08-03
00840493425726RIVA Pedicle Screw SystemFG1-16-300110FG1-16-3001102026-08-03
00840493425382RIVA Pedicle Screw SystemFG1-15-300085FG1-15-3000852026-07-28
00840493425399RIVA Pedicle Screw SystemFG1-15-300090FG1-15-3000902026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843511102586Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102593Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102609Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102616Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102623Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102630Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102647Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102654Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102661Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102678Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102685Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102692Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102708Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102715Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102722Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102739Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102746Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102753Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102760Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102777Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102784Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102791Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102807Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102814Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102821Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102838Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102845Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00889929072929HONOUR® Spacer SystemNEXXT SPINE, LLCODP2026-07-29
00889929072936HONOUR® Spacer SystemNEXXT SPINE, LLCODP2026-07-29
B064XMPHC1640202Ø4.0mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCODP2026-07-28