FDA.reportPublic FDA data

ReLine

Primary DI
00195377147745
Brand
ReLine
Company
Nuvasive, Inc.
Model
10001688
Device description
RELINE Counter Torque, Conn DualModSxS
Published
2023-08-18
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
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
K223181000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223181000NuVasive Reline SystemNu Vasive, Incorporated2023-01-11NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195377147745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195377147745001953771477451953771477450195377147745

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation procedure kit, reusableA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(858)909-1800RA_UDI@nuvasive.com
+1(858)909-1800nuvainfo@globusmedical.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
00887517127693MaXcess707042270704222026-07-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157113384ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113391ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113407ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113414ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113421ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113438ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113445ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113452ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113469ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113476ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113483ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113490ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113506ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113513ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113520ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113537ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113544ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113551ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113568ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113575ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113582ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113599ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113605ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113612ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113629ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113636ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113643ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113650ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113667ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113674ZAVATION SCREWZavation LLCNKB2026-09-04