FDA.reportPublic FDA data

VuePoint

Primary DI
00887517954398
Brand
VuePoint
Company
Nuvasive, Inc.
Model
8980000P
Device description
VuePoint II Keel Plate + Set Screws
Published
2018-07-30
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
00887517954398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517954398008875179543988875179543980887517954398

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

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

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
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-18
00763000992576INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992583INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992590INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992606INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992613INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992620INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992712INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992729INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992736INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992743INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992750INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992767INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992774INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992781INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992798INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992804INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992897INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992903INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992910INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992927INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992934INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992941INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992958INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992965INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992972INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992989INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000993078INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17