FDA.reportPublic FDA data

CoRoent

Primary DI
00887517416346
Brand
CoRoent
Company
Nuvasive, Inc.
Model
D1658095
Device description
Oblique TLIF Inserter, 14x25mm Impact QC
Published
2017-07-07
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
MAXIntervertebral fusion device with bone graft, lumbar
PHMIntervertebral fusion device with bone graft, thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
PHMIntervertebral Fusion Device With Bone Graft, ThoracicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170962000NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017-06-26MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517416346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517416346008875174163468875174163460887517416346

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic graft inserterA hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., stainless steel or titanium (Ti)] used to advance the graft down its tubular-shaped holder or possibly a bone graft funnel and into place; it is also available in a variety of sizes. 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
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
04251631420200NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420217NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420224NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420231NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420248NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420255NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420262NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420279NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420286NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420293NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420309NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420316NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420323NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420330NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420347NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420354NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420361NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420378NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420385NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420392NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420408NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420415NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420422NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420439NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420446NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420453NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420460NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420477NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420484NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420491NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06