FDA.reportPublic FDA data

neoWave LS

Primary DI
00818345024632
Brand
neoWave LS
Company
XENIX MEDICAL LLC
Model
23-LTT-2512
Device description
Lumbar Trial, Straight Oblique, 25x10mm, 12mm, 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
00818345024632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345024632008183450246328183450246320818345024632

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
00840493441634RIVA Pedicle Screw SystemFG1-A3-021922FG1-A3-0219222026-10-05
00840493441641LUX Expandable Interbody SystemLE1-A4-000560LE1-A4-0005602026-10-05
00840493441658LUX Expandable Interbody SystemLE1-A4-000570LE1-A4-0005702026-10-05
00840493441665RIVA Pedicle Screw SystemFG1-A1-000063FG1-A1-0000632026-10-05
00840493441672RIVA Pedicle Screw SystemFG1-A3-000081FG1-A3-0000812026-10-05
00840493441689RIVA Pedicle Screw SystemFG1-A3-000040FG1-A3-0000402026-10-05
00840493441696RIVA Pedicle Screw SystemFG1-A5-000013FG1-A5-0000132026-10-05
00840493441719RIVA Pedicle Screw SystemFG1-A1-000064FG1-A1-0000642026-10-05
00840493442020Xenix Medical Universal HandleUN1-H0-423005UN1-H0-4230052026-10-05
00840493442037Xenix Medical Universal HandleUN1-H0-423006UN1-H0-4230062026-10-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809974809440Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809457Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809464Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809471Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809488Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809495Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809501Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809518Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809525Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809532Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809549Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809556Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809563Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809570Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809587Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809594Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809600Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809617Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809624Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809631Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809648Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809655Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809662Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974818879Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974836231Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974836286Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974837856Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974837955Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974839355Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974849590Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19