FDA.reportPublic FDA data

Radian

Primary DI
00887517255723
Brand
Radian
Company
Nuvasive, Inc.
Model
5544555
Device description
Radian Facet Screw, 4.5x55mm
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRWSYSTEM, FACET SCREW SPINAL DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101284000FACET SCREW SYSTEMNuvasive, Inc.2010-07-15MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517255723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517255723008875172557238875172557230887517255723

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

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
00810131885045ION Non CervicalSurgentec, LLCMRW2026-07-28
00810131882761Facet Sterile Implant - 55Surgentec, LLCMRW2026-07-06
00810131882808Facet Sterile Instrument Kit - CervicalSurgentec, LLCMRW2026-07-06
00810131884772ION-C Final KitSurgentec, LLCMRW2026-07-06
00810131884895ION-C ReusableSurgentec, LLCMRW2026-07-06
00810131881795ION Disposable Instrument KitSurgentec, LLCMRW2026-03-09
00810131881801ION 55 Facet Implant - SterileSurgentec, LLCMRW2026-03-09
00810131881818ION 60 Facet Implant - SterileSurgentec, LLCMRW2026-03-09
00810131881825ION 65 Facet Implant - SterileSurgentec, LLCMRW2026-03-09
07290019421245Facet ScrewZYGOFIX LTDMRW2024-10-20
07290019421238Facet screwZYGOFIX LTDMRW2024-09-05
00840916160135SPARTANSPINAL ELEMENTSMRW2020-12-07
08800039819909FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819916FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819923FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819930FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819947FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819954FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819961FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819978FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819985FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039819992FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820004FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820011FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820028FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820035FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820042FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820059FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820318FasetDIOMEDICAL CO.,LTD.MRW2019-02-08
08800039820325FasetDIOMEDICAL CO.,LTD.MRW2019-02-08