FDA.reportPublic FDA data

NeoFuse HA Enhanced PLIF/TLIF

Primary DI
00818345020566
Brand
NeoFuse HA Enhanced PLIF/TLIF
Company
XENIX MEDICAL LLC
Model
A2412-12
Device description
HA CAGE 24L x 12W x 12H
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
K153615000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153615000NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC2016-05-06MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818345020566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345020566008183450205668183450205660818345020566

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

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
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
00840493424743RIVA Pedicle Screw SystemFG1-15-240050FG1-15-2400502026-07-13
00840493424750RIVA Pedicle Screw SystemFG1-15-240055FG1-15-2400552026-07-13
00840493424767RIVA Pedicle Screw SystemFG1-15-240060FG1-15-2400602026-07-13
00840493424774RIVA Pedicle Screw SystemFG1-15-240065FG1-15-2400652026-07-13
00840493424781RIVA Pedicle Screw SystemFG1-15-240070FG1-15-2400702026-07-13
00840493424798RIVA Pedicle Screw SystemFG1-15-240075FG1-15-2400752026-07-13
00840493424804RIVA Pedicle Screw SystemFG1-15-240080FG1-15-2400802026-07-13
00840493424811RIVA Pedicle Screw SystemFG1-15-240085FG1-15-2400852026-07-13
00840493424828RIVA Pedicle Screw SystemFG1-15-240090FG1-15-2400902026-07-13
00840493424835RIVA Pedicle Screw SystemFG1-15-240095FG1-15-2400952026-07-13
00840493424842RIVA Pedicle Screw SystemFG1-15-240100FG1-15-2401002026-07-13
00840493424859RIVA Pedicle Screw SystemFG1-15-240110FG1-15-2401102026-07-13
00840493424866RIVA Pedicle Screw SystemFG1-15-240120FG1-15-2401202026-07-13
00840493424873RIVA Pedicle Screw SystemFG1-15-240130FG1-15-2401302026-07-13
00840493424880RIVA Pedicle Screw SystemFG1-15-240140FG1-15-2401402026-07-13
00840493424897RIVA Pedicle Screw SystemFG1-15-240150FG1-15-2401502026-07-13
00840493424903RIVA Pedicle Screw SystemFG1-15-240200FG1-15-2402002026-07-13

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