FDA.reportPublic FDA data

ReLine

Primary DI
00887517540140
Brand
ReLine
Company
Nuvasive, Inc.
Model
13025570
Device description
RELINE-O Screw, 5.5x70mm 2S Reduction
Published
2015-09-30
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
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease
OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143684000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143684000NuVasive Reline SystemNu Vasive, Incorporated2015-04-23NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517540140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517540140008875175401408875175401400887517540140

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-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. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam 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
00810017916450Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00810017916467Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00810017916474Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00810017916481Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00810017916498Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00840493423531RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-10
00840493423531RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-10
00840493423548RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-10
00840493423548RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-10
00840493423555RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-10
00840493423555RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-10
00841732149847TAURUS Pedicle Screw SystemCTL Medical CorporationMNI2023-09-15
00841732149847TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-15
00841732149847TAURUS Pedicle Screw SystemCTL Medical CorporationMNH2023-09-15
00841732149847TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-15
00841732149854TAURUS Pedicle Screw SystemCTL Medical CorporationMNI2023-09-15
00841732149854TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-15
00841732149854TAURUS Pedicle Screw SystemCTL Medical CorporationMNH2023-09-15
00841732149854TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-15
00841732149199TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-09
00841732149199TAURUS Pedicle Screw SystemCTL Medical CorporationMNH2023-09-09
00841732149199TAURUS Pedicle Screw SystemCTL Medical CorporationMNI2023-09-09
00841732149199TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-09
00841732149205TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-09
00841732149205TAURUS Pedicle Screw SystemCTL Medical CorporationMNI2023-09-09
00841732149205TAURUS Pedicle Screw SystemCTL Medical CorporationMNH2023-09-09
00841732149205TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-09
00841732149212TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2023-09-09
00841732149212TAURUS Pedicle Screw SystemCTL Medical CorporationMNI2023-09-09
00841732149212TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-09