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

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
00887517614360Propel50200012015-09-24
00887517614377Propel50200052015-09-24
00887517614384Propel50200102015-09-24
00887517939951AttraX50151102018-06-05
00887517939968AttraX50151202018-06-05
00887517939975AttraX50151302018-06-05
00887517939982AttraX50151032018-06-05
00887517939999AttraX50151042018-06-05
00887517940001AttraX50151062018-06-05
00887517940018AttraX50151012018-06-05
00887517940025AttraX50151022018-06-05
00887517970435Propel50202052018-12-20
00887517970442Propel50202059942018-12-20
00887517970459Propel50202102018-12-20
00887517970466Propel50202109942018-12-20
00887517970473Propel50203012018-12-20
00887517970480Propel50203019942018-12-20
00887517970497Propel50203052018-12-20
00887517971500Propel50203059942018-12-20
00887517971517Propel50203102018-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840019978484Reform TiPRECISION SPINE, INC.KWP2026-11-05
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00840019978507Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978514Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978521Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978538Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978545Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978552Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978569Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978576Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978583Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978590Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978606Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978613Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978620Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978637Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978644Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978651Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978668Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978675Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978682Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978699Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978705Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978712Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978729Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978736Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978743Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978750Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978767Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978774Reform TiPRECISION SPINE, INC.KWP2026-11-05