FDA.reportPublic FDA data

CoRoent

Primary DI
00887517361257
Brand
CoRoent
Company
Nuvasive, Inc.
Model
6790172
Device description
CoRoent Small Interlock Inserter
Published
2019-12-16
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
00887517361257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517361257008875173612578875173612570887517361257

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
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
00843511102586Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102593Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102609Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102616Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102623Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102630Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102647Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102654Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102661Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102678Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102685Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102692Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102708Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102715Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102722Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102739Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102746Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102753Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102760Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102777Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102784Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102791Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102807Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102814Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102821Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102838Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102845Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00889929072929HONOUR® Spacer SystemNEXXT SPINE, LLCODP2026-07-29
00889929072936HONOUR® Spacer SystemNEXXT SPINE, LLCODP2026-07-29
B064XMPHC1640202Ø4.0mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCODP2026-07-28