FDA.reportPublic FDA data

VuePoint

Primary DI
00887517954251
Brand
VuePoint
Company
Nuvasive, Inc.
Model
8976124P
Device description
VuePoint II Rod, 3.5x240mm
Published
2018-07-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00887517954251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517954251008875179542518875179542510887517954251

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
Manufacturing date on label
true
Expiration date on label
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
00197157082130ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082147ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082154ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082161ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082178ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082185ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082192ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082208ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082215ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082222ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082239ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082246ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082253ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082260ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082277ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082284ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082291ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082307ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082314ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082321ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082338ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082345ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082352ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082369ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082376ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082383ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082390ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082406ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082413ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082420ZAVATION SCREWZavation LLCKWP2026-07-23