FDA.reportPublic FDA data

Affix

Primary DI
00887517063687
Brand
Affix
Company
Nuvasive, Inc.
Model
7579040
Device description
Affix II S Bladed Plate, 40mm
Published
2019-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
PEKSpinous process plate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
PEKSpinous Process PlateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073278000
K131238000
K132411000
K133052000
K143388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073278000SPINOUS PROCESS PLATE SYSTEMNuvasive, Inc.2008-03-28KWP
K131238000AFFIX SPINOUS PROCESS PLATE SYSTEMNuvasive, Inc.2013-07-02PEK
K132411000AFFIX II SPINOUS PROCESS PLATE SYSTEMNu Vasive, Incorporated2013-11-20PEK
K133052000AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEMNuvasive, Inc.2013-12-20PEK
K143388000Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated2015-03-05PEK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517063687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517063687008875170636878875170636870887517063687

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar interspinous decompression spacer, non-sterileA non-sterile device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is typically designed as a small spacer, either a single-piece or assembly, made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and/or synthetic polymer [e.g., hydrogel, polyetheretherketone (PEEK)]. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(858)909-1800RA_UDI@nuvasive.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags#

DUNS number
053950783
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517127693MaXcess707042270704222026-07-27
00887517065100ACP18008223180082232026-04-25
00887517065124ACP18008312180083122026-04-25
00887517065162ACP18008316180083162026-04-25
00887517065186ACP18008318180083182026-04-25
00887517065384ACP18008512180085122026-04-25
00887517065612ACP18008622180086222026-04-25
00887517065643ACP18009117180091172026-04-25
00887517065667ACP18009119180091192026-04-25
00887517065681ACP18009121180091212026-04-25
00887517065926ACP18009229180092292026-04-25
00887517100412VuePoint897711589771152026-04-25
00887517156297ReLine11010511110105112026-04-25
00887517156822ReLine11010530110105302026-04-25
00887517378828CoRoent685121768512172026-04-25
00887517413673MAS PLIF707004270700422026-04-25
00887517645135CoRoent680050868005082026-04-25
00887517645142CoRoent680051068005102026-04-25
00887517645166CoRoent680051468005142026-04-25
00887517645173CoRoent680150868015082026-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857037953EVEREST® Spinal SystemVB Spine LLCKWP2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCKWP2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857046733MESA® Small Stature Spinal SystemVB Spine LLCKWP2016-09-02
10888857008724EVEREST® Spinal SystemVB Spine LLCKWP2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001763DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001787DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001824DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001848DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001923DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001947DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001978DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001992DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002036DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002050DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002074DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002098DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24