FDA.reportPublic FDA data

ReLine

Primary DI
00887517044556
Brand
ReLine
Company
Nuvasive, Inc.
Model
16419510P
Device description
RELINE MAS Screw+LS, 9.5x100mm 2C P.I.
Published
2021-02-25
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
NKBThoracolumbosacral pedicle screw system
PMLbone cement, posterior screw augmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
PMLBone Cement, Posterior Screw AugmentationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180498000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180498000NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated2018-11-28PML

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517044556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517044556008875170445568875170445560887517044556

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
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
00840493423531RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-10
00840493423548RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-10
00840493423555RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-10
00887517656582ReLineNuvasive, Inc.NKB2026-04-15
00887517656582ReLineNuvasive, Inc.KWP2026-04-15
00841732149847TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-15
00841732149847TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-15
00841732149854TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-15
00841732149854TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-15
00841732150621TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-15
00841732150621TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-15
00841732164031TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732164031TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-14
00841732164048TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-14
00841732164048TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732164055TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732164055TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-14
00841732164062TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-14
00841732164062TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732164079TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732164079TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-14
00841732164086TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732164086TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-14
00841732164130TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732164130TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-14
00841732164208TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732164208TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-14
00841732164345TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-14
00841732164345TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732149199TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-09