FDA.reportPublic FDA data

NeoFuse Ti3D PLIF/TLIF

Primary DI
00818345021914
Brand
NeoFuse Ti3D PLIF/TLIF
Company
XENIX MEDICAL LLC
Model
C3212-15
Device description
Ti3D CAGE 32L x 12W x 15H
Published
2017-11-07
Public version status
Update
Distribution status
Not 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
K170318000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170318000NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC2017-07-12ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818345021914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345021914008183450219148183450219140818345021914

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia screenA frame-like device designed to provide a barrier between the sterile surgical site (i.e., where the surgeon operates) and the non-sterile area where the anaesthesiologists and other staff work during a procedure. It is typically fixed to the side rail of the operating table, and surgical drapes are hung over it or from it to create the hygienic partition. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
918-995-2090customerservice@htspine.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493425382RIVA Pedicle Screw SystemFG1-15-300085FG1-15-3000852026-07-28
00840493425399RIVA Pedicle Screw SystemFG1-15-300090FG1-15-3000902026-07-28
00840493425405RIVA Pedicle Screw SystemFG1-15-300095FG1-15-3000952026-07-28
00840493425412RIVA Pedicle Screw SystemFG1-15-300100FG1-15-3001002026-07-28
00840493425429RIVA Pedicle Screw SystemFG1-15-300110FG1-15-3001102026-07-28
00840493425436RIVA Pedicle Screw SystemFG1-15-300120FG1-15-3001202026-07-28
00840493425443RIVA Pedicle Screw SystemFG1-15-300130FG1-15-3001302026-07-28
00840493425450RIVA Pedicle Screw SystemFG1-15-300140FG1-15-3001402026-07-28
00840493425467RIVA Pedicle Screw SystemFG1-15-300150FG1-15-3001502026-07-28
00840493425474RIVA Pedicle Screw SystemFG1-15-300200FG1-15-3002002026-07-28
00840493425481RIVA Pedicle Screw SystemFG1-15-300250FG1-15-3002502026-07-28
00840493425498RIVA Pedicle Screw SystemFG1-15-300300FG1-15-3003002026-07-28
00840493425504RIVA Pedicle Screw SystemFG1-15-300350FG1-15-3003502026-07-28
00840493425511RIVA Pedicle Screw SystemFG1-15-300400FG1-15-3004002026-07-28
00840493425528RIVA Pedicle Screw SystemFG1-15-300450FG1-15-3004502026-07-28
00840493425535RIVA Pedicle Screw SystemFG1-15-300500FG1-15-3005002026-07-28
00840493425542RIVA Pedicle Screw SystemFG1-15-300550FG1-15-3005502026-07-28
00840493424712RIVA Pedicle Screw SystemFG1-16-231600FG1-16-2316002026-07-13
00840493424729RIVA Pedicle Screw SystemFG1-15-240040FG1-15-2400402026-07-13
00840493424736RIVA Pedicle Screw SystemFG1-15-240045FG1-15-2400452026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810166521604X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521611X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521765X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166523028X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
04251631420095NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420101NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420118NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420125NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420132NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420149NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420156NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420163NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420170NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420187NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420194NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421153BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421177BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421184BEE PLIF CageNGMedical GmbHMAX2026-07-30
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04251631421214BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421221BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421252BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421269BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421276BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421283BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421306BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421313BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421320BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421337BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421351BEE PLIF CageNGMedical GmbHMAX2026-07-30