FDA.reportPublic FDA data

VuePoint

Primary DI
00887517826596
Brand
VuePoint
Company
Nuvasive, Inc.
Model
8980120P3
Device description
VuePoint II Screw/Set Screw, 4.0x20mm MA
Published
2019-04-08
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKGOrthosis, cervical pedicle screw spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180198000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180198000NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated2018-03-15NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517826596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517826596008875178265968875178265960887517826596

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Radiation 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
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
00887517645180CoRoent680151068015102026-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901035PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901615PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901622PrimusSPINAL ELEMENTS, INC.KWP2026-07-21