FDA.reportPublic FDA data

Modulus

Primary DI
00887517020475
Brand
Modulus
Company
Nuvasive, Inc.
Model
1921074P2
Device description
Modulus ALIF HL, 8x38x30mm 25°
Published
2021-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193593000NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020-03-25OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517020475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517020475008875170204758875170204750887517020475

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Radiation 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
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517614360Propel50200012015-09-24
00887517614377Propel50200052015-09-24
00887517614384Propel50200102015-09-24
00887517939951AttraX50151102018-06-05
00887517939968AttraX50151202018-06-05
00887517939975AttraX50151302018-06-05
00887517939982AttraX50151032018-06-05
00887517939999AttraX50151042018-06-05
00887517940001AttraX50151062018-06-05
00887517940018AttraX50151012018-06-05
00887517940025AttraX50151022018-06-05
00887517970435Propel50202052018-12-20
00887517970442Propel50202059942018-12-20
00887517970459Propel50202102018-12-20
00887517970466Propel50202109942018-12-20
00887517970473Propel50203012018-12-20
00887517970480Propel50203019942018-12-20
00887517970497Propel50203052018-12-20
00887517971500Propel50203059942018-12-20
00887517971517Propel50203102018-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916139SABER-XA, Anterior Plate, 34Wx11HELEVATION SPINE, INC.OVD2026-10-23
00810017916146SABER-XA, Anterior Plate, 34Wx13HELEVATION SPINE, INC.OVD2026-10-23
00810017916153SABER-XA, Anterior Plate, 34Wx16HELEVATION SPINE, INC.OVD2026-10-23
00810017916207SABER-XA, Anterior Plate, 37Wx11HELEVATION SPINE, INC.OVD2026-10-23
00810017916221SABER-XA, Anterior Plate, 37Wx16HELEVATION SPINE, INC.OVD2026-10-23
00810017916276SABER-XA, Anterior Plate, 40Wx11HELEVATION SPINE, INC.OVD2026-10-23
00810017916283SABER-XA, Anterior Plate, 40Wx13HELEVATION SPINE, INC.OVD2026-10-23
00810017916290SABER-XA, Anterior Plate, 40Wx16HELEVATION SPINE, INC.OVD2026-10-23
00840606187626Ventana ASPINAL ELEMENTS, INC.OVD2026-10-22
10889981217204MeridianSeaspine Orthopedics CorporationOVD2022-08-25
10889981230906RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230913RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230920RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230937RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230944RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230951RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230968RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230975RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230982RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230999RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231002RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231019RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231026RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231033RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231248RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231255RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231262RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981214395MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214401MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214418MeridianSeaspine Orthopedics CorporationOVD2020-12-30