FDA.reportPublic FDA data

CoRoent

Primary DI
00887517817907
Brand
CoRoent
Company
Nuvasive, Inc.
Model
1835687
Device description
CoRoent SLP Trial Drill Guide,14x15x13mm
Published
2017-09-09
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
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163491000NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017-03-24ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517817907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517817907008875178179078875178179070887517817907

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/trial-implant holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft) or trial implant to facilitate guidance, gauging, and monitoring of the implant or trial implant during the orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic materials and is typically constructed in the form of a long shaft with a handle at the proximal end and an implant holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). 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
+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
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
18257200030743CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030767CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030781CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030804CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030828CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030842CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030866CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030880CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030903CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030927CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030965CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031023CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031047CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031061CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031085CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031108CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031122CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031146CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031160CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031184CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031207CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031221CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031245CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031269CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031283CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031306CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031320CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031344CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031368CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031382CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17