FDA.reportPublic FDA data

neoWave LS

Primary DI
00818345026292
Brand
neoWave LS
Company
XENIX MEDICAL LLC
Model
23-K01-0650
Catalog number
N/A
Device description
Removal Tool
Published
2022-03-31
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
LXHOrthopedic Manual Surgical Instrument
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180401000
K182210000
K222988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180401000TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC2018-06-14ODP
K182210000TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC2019-01-07MAX
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
00818345026292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345026292008183450262928183450262920818345026292

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
Moist Heat or Steam Sterilization

Contacts#

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

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
00840493426426RIVA Pedicle Screw SystemFG1-16-302065FG1-16-3020652026-08-18
00840493426433RIVA Pedicle Screw SystemFG1-16-302070FG1-16-3020702026-08-18
00840493426440RIVA Pedicle Screw SystemFG1-16-302075FG1-16-3020752026-08-18
00840493426457RIVA Pedicle Screw SystemFG1-16-302080FG1-16-3020802026-08-18
00840493426464RIVA Pedicle Screw SystemFG1-16-302085FG1-16-3020852026-08-18
00840493426471RIVA Pedicle Screw SystemFG1-16-302090FG1-16-3020902026-08-18
00840493426488RIVA Pedicle Screw SystemFG1-16-302095FG1-16-3020952026-08-18
00840493426495RIVA Pedicle Screw SystemFG1-16-302100FG1-16-3021002026-08-18
00840493426501RIVA Pedicle Screw SystemFG1-16-302110FG1-16-3021102026-08-18
00840493426518RIVA Pedicle Screw SystemFG1-16-302120FG1-16-3021202026-08-18
00840493426525RIVA Pedicle Screw SystemFG1-16-302130FG1-16-3021302026-08-18
00840493426532RIVA Pedicle Screw SystemFG1-16-302140FG1-16-3021402026-08-18
00840493426549RIVA Pedicle Screw SystemFG1-16-302150FG1-16-3021502026-08-18
00840493426556RIVA Pedicle Screw SystemFG1-16-302200FG1-16-3022002026-08-18
00840493426563RIVA Pedicle Screw SystemFG1-16-302250FG1-16-3022502026-08-18
00840493426570RIVA Pedicle Screw SystemFG1-16-302300FG1-16-3023002026-08-18
00840493426587RIVA Pedicle Screw SystemFG1-16-302350FG1-16-3023502026-08-18
00840493426594RIVA Pedicle Screw SystemFG1-16-302400FG1-16-3024002026-08-18
00840493426600RIVA Pedicle Screw SystemFG1-16-302450FG1-16-3024502026-08-18
00840493426617RIVA Pedicle Screw SystemFG1-16-302500FG1-16-3025002026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M9432002220000MinutemanSpinal Simplicity, LLCLXH2026-09-04
07613327697209PANGEAStryker GmbHLXH2026-08-27
00840311258635C-Plus PEEK IBF SystemXtant Medical Holdings, Inc.ODP2026-08-26
00840606185950ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185967ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185974ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185981ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185998ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186001ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186018ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186025ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186032ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186049ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186056ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186063ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186070ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186087ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186094ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186100ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186117ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186124ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186131ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186148ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186155ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186162ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186179ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186186ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186193ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186209ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186247ALIFSPINAL ELEMENTS, INC.LXH2026-08-26