FDA.reportPublic FDA data

neoWave LS

Primary DI
00818345024625
Brand
neoWave LS
Company
XENIX MEDICAL LLC
Model
23-LTT-2511
Device description
Lumbar Trial, Straight Oblique, 25x10mm, 11mm, 8 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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182210000
K222988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
00818345024625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345024625008183450246258183450246250818345024625

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
00840493423166RIVA Pedicle Screw SystemFG1-16-202025FG1-16-2020252026-06-08
00840493423173RIVA Pedicle Screw SystemFG1-16-202030FG1-16-2020302026-06-08
00840493423180RIVA Pedicle Screw SystemFG1-16-202035FG1-16-2020352026-06-08
00840493423197RIVA Pedicle Screw SystemFG1-16-202040FG1-16-2020402026-06-08
00840493423203RIVA Pedicle Screw SystemFG1-16-202045FG1-16-2020452026-06-08
00840493423210RIVA Pedicle Screw SystemFG1-16-202050FG1-16-2020502026-06-08
00840493423227RIVA Pedicle Screw SystemFG1-16-202055FG1-16-2020552026-06-08
00840493423234RIVA Pedicle Screw SystemFG1-16-202060FG1-16-2020602026-06-08
00840493423241RIVA Pedicle Screw SystemFG1-16-202065FG1-16-2020652026-06-08
00840493423258RIVA Pedicle Screw SystemFG1-16-202070FG1-16-2020702026-06-08
00840493423265RIVA Pedicle Screw SystemFG1-16-202075FG1-16-2020752026-06-08
00840493423272RIVA Pedicle Screw SystemFG1-16-202080FG1-16-2020802026-06-08
00840493423289RIVA Pedicle Screw SystemFG1-16-202085FG1-16-2020852026-06-08
00840493423296RIVA Pedicle Screw SystemFG1-16-202090FG1-16-2020902026-06-08
00840493423302RIVA Pedicle Screw SystemFG1-16-202095FG1-16-2020952026-06-08
00840493423319RIVA Pedicle Screw SystemFG1-16-202100FG1-16-2021002026-06-08
00840493423326RIVA Pedicle Screw SystemFG1-16-202110FG1-16-2021102026-06-08
00840493423333RIVA Pedicle Screw SystemFG1-16-202120FG1-16-2021202026-06-08
00840493423340RIVA Pedicle Screw SystemFG1-16-202130FG1-16-2021302026-06-08
00840493423357RIVA Pedicle Screw SystemFG1-16-202140FG1-16-2021402026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043966040N/ATDM Co., Ltd.MAX2026-06-08
08800043966057N/ATDM Co., Ltd.MAX2026-06-08
08800043966064N/ATDM Co., Ltd.MAX2026-06-08
08800043966071N/ATDM Co., Ltd.MAX2026-06-08
08800043966088N/ATDM Co., Ltd.MAX2026-06-08
08800043966095N/ATDM Co., Ltd.MAX2026-06-08
08800043966101N/ATDM Co., Ltd.MAX2026-06-08
08800043966118N/ATDM Co., Ltd.MAX2026-06-08
08800043966125N/ATDM Co., Ltd.MAX2026-06-08
08800043966132N/ATDM Co., Ltd.MAX2026-06-08
08800043966149N/ATDM Co., Ltd.MAX2026-06-08
08800043966156N/ATDM Co., Ltd.MAX2026-06-08
08800043966163N/ATDM Co., Ltd.MAX2026-06-08
08800043966170N/ATDM Co., Ltd.MAX2026-06-08
08800043966187N/ATDM Co., Ltd.MAX2026-06-08
08800043966194N/ATDM Co., Ltd.MAX2026-06-08
08800043966200N/ATDM Co., Ltd.MAX2026-06-08
08800043966217N/ATDM Co., Ltd.MAX2026-06-08
08800043966224N/ATDM Co., Ltd.MAX2026-06-08
08800043966231N/ATDM Co., Ltd.MAX2026-06-08
08800043966248N/ATDM Co., Ltd.MAX2026-06-08
08800043966255N/ATDM Co., Ltd.MAX2026-06-08
08800043966262N/ATDM Co., Ltd.MAX2026-06-08
08800043966279N/ATDM Co., Ltd.MAX2026-06-08
08800043966286N/ATDM Co., Ltd.MAX2026-06-08
08800043966293N/ATDM Co., Ltd.MAX2026-06-08
08800043966309N/ATDM Co., Ltd.MAX2026-06-08
08800043966316N/ATDM Co., Ltd.MAX2026-06-08
08800043966323N/ATDM Co., Ltd.MAX2026-06-08
08800043966330N/ATDM Co., Ltd.MAX2026-06-08