FDA.reportPublic FDA data

Modulus

Primary DI
00195377045379
Brand
Modulus
Company
Nuvasive, Inc.
Model
1460250
Device description
Modulus ALIF Bolt, Ø6.0x25mm Fixation
Published
2021-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K210271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210271000NuVasive Modulus ALIF SystemNu Vasive, Incorporated2021-03-01OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195377045379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195377045379001953770453791953770453790195377045379

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+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
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
G070SPX01505300000OneLIF™Novapproach Spine LLCOVD2026-10-30
00810017916191SABER-XA, Expandable Spacer, 37x28mm, 16mm, (18°)ELEVATION SPINE, INC.OVD2026-10-27
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
B06217500000Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-24
B06217500001Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-24
B06217900001Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-24
B06217200001Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-23
B06217205422Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-23
B06217205425Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-23
B06217205035Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205038Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205040Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205043Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205045Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205048Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205050Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205053Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205115Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205118Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205120Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205123Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19
B06217205125Pisces-SAOsseus Fusion Systems, LLCOVD2022-05-19