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
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

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Primary DI, Brand, Company table
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B707125355730600DUALX DUAL PORTAL DISPOSABLE KIT-60MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730700DUALX DUAL PORTAL DISPOSABLE KIT-70MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
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B707125355730900DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
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B707125355731100DUALX DUAL PORTAL DISPOSABLE KIT-110MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731200DUALX DUAL PORTAL DISPOSABLE KIT-120MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
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