FDA.reportPublic FDA data

neoWave LS

Primary DI
00818345024342
Brand
neoWave LS
Company
XENIX MEDICAL LLC
Model
23-LCT-2216
Catalog number
N/A
Device description
LUMBAR CAGE, 10W x 22L x 16H, 8 DEG, STRAIGHT
Published
2020-06-26
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
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
00818345024342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345024342008183450243428183450243420818345024342

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@htmedicalusa.com
888-594-8633cs@xenixmedical.com

Regulatory Flags#

DUNS number
080386764
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493422596RIVA Pedicle Screw SystemFG1-16-200200FG1-16-2002002026-06-05
00840493422602RIVA Pedicle Screw SystemFG1-16-200250FG1-16-2002502026-06-05
00840493422619RIVA Pedicle Screw SystemFG1-16-200300FG1-16-2003002026-06-05
00840493422626RIVA Pedicle Screw SystemFG1-16-200350FG1-16-2003502026-06-05
00840493422633RIVA Pedicle Screw SystemFG1-16-200400FG1-16-2004002026-06-05
00840493422640RIVA Pedicle Screw SystemFG1-16-200450FG1-16-2004502026-06-05
00840493422657RIVA Pedicle Screw SystemFG1-16-200500FG1-16-2005002026-06-05
00840493422664RIVA Pedicle Screw SystemFG1-16-200550FG1-16-2005502026-06-05
00840493422671RIVA Pedicle Screw SystemFG1-16-200600FG1-16-2006002026-06-05
00840493422688RIVA Pedicle Screw SystemFG1-15-201200FG1-15-2012002026-06-05
00840493422695RIVA Pedicle Screw SystemFG1-15-201250FG1-15-2012502026-06-05
00840493422701RIVA Pedicle Screw SystemFG1-15-201300FG1-15-2013002026-06-05
00840493422718RIVA Pedicle Screw SystemFG1-15-201350FG1-15-2013502026-06-05
00840493422725RIVA Pedicle Screw SystemFG1-15-201400FG1-15-2014002026-06-05
00840493422732RIVA Pedicle Screw SystemFG1-15-201450FG1-15-2014502026-06-05
00840493422749RIVA Pedicle Screw SystemFG1-15-201500FG1-15-2015002026-06-05
00840493422756RIVA Pedicle Screw SystemFG1-15-201550FG1-15-2015502026-06-05
00840493422763RIVA Pedicle Screw SystemFG1-15-201600FG1-15-2016002026-06-05
00840493422770RIVA Pedicle Screw SystemFG1-16-201200FG1-16-2012002026-06-05
00840493422787RIVA Pedicle Screw SystemFG1-16-201250FG1-16-2012502026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840283403460LumiVy™VY SPINE LLCMAX2026-06-05
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02