FDA.reportPublic FDA data

ReLine

Primary DI
00887517049315
Brand
ReLine
Company
Nuvasive, Inc.
Model
10250112P
Catalog number
10250112P
Device description
RSS Iliac Saddle, 5.0mm Straight Ø12
Published
2026-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAppliance, fixation, spinal intervertebral body
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190636000NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated2019-10-19NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517049315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517049315008875170493158875170493150887517049315

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system hookAn implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00887517729071MaXcess35000172019-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075835ZAVATION DRIVERZavation LLCNKB2026-05-27
00197157075842ZAVATION K-WIREZavation LLCNKB2026-05-27
00840354203654Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203661Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203678Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203685Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203692Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203708Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203715Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203722Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203739Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203746Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203753Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203760Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203777Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203784Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203791Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203807Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203814Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203821Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203838Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203845Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203852Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203869Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203876Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203883Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203890Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203906Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203913Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203920Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06