FDA.reportPublic FDA data

SpheRx

Primary DI
00887517460080
Brand
SpheRx
Company
Nuvasive, Inc.
Model
7270300
Device description
SpheRx DBR II K-Wire, X-Long Thread Tip
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517460080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517460080008875174600808875174600800887517460080

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation procedure kit, single-useA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device.

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
Premarket exempt
true
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517656582ReLine13125560131255602026-04-15
00887517377692CoRoent68510122015-10-24
00887517390516CoRoent69102452015-10-24
00195377006424CoRoent6791713P26791713P22026-05-08
00195377006431CoRoent6791712P26791712P22026-05-08
00887517051905CoRoent6791715P26791715P22026-05-08
00887517051912CoRoent6791716P26791716P22026-05-08
00887517051929CoRoent6791812P26791812P22026-05-08
00887517051936CoRoent6791813P26791813P22026-05-08
00887517051943CoRoent6791814P26791814P22026-05-08
00887517051950CoRoent6791815P26791815P22026-05-08
00887517051967CoRoent6791816P26791816P22026-05-08
00887517180513MaXcess32000282022-07-20
00887517063434MaXcess10109872019-11-21
00887517074973MaXcess10254612019-11-21
00887517183323MaXcess32001202019-11-21
00887517183378MaXcess32002202019-11-21
00887517206084MaXcess34000332019-11-21
00887517206572MaXcess34000442019-11-21
00887517497222MaXcess32410022019-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630542776755Surgical Manual InstrumentMedacta International SALXH2026-07-07
07630542778285Surgical Manual InstrumentMedacta International SALXH2026-07-07
07630542778292Surgical Manual InstrumentMedacta International SALXH2026-07-07
07630542791659Surgical Manual InstrumentMedacta International SALXH2026-07-07
07899258616506Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258625348Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258625355Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258633350Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258633367Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258633374Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258633381Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258634388Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258636290Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258645094Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258646527Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258655864Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258655871Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258655932Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258655949Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258656151Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258695464Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258695471Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
07899258695488Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-07
00860011177814Wright-Out Hip Stem Extractor Guide Block and Osteotome Blade KitMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
00860011177838Wright-Out Hip Stem Extractor Slide HammerMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
00860011177845Wright-Out Hip Stem Extractor Osteotome HandleMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
00860011177852Wright-Out Hip Stem Extractor 5/64" T-Handle Hex KeyMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
00860011177869Wright-Out Hip Stem Extractor 10mm T-Handle Socket WrenchMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
03770019503416Drill - Screw D.3,5mm-L.18SC MEDICALXH2026-07-03
03770019503867Cannulated Screwdriver tip for screw D3,5mm-L.16SC MEDICALXH2026-07-03