FDA.reportPublic FDA data

Modulus

Primary DI
00195377150639
Brand
Modulus
Company
Nuvasive, Inc.
Model
1305225
Device description
Modulus ALIF Blade, Ø5.0x22.5mm
Published
2023-09-01
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
MAXIntervertebral fusion device with bone graft, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230894000NuVasive Modulus ALIF SystemNu Vasive, Incorporated2023-06-16OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195377150639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195377150639001953771506391953771506390195377150639

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(858)909-1800RA_UDI@nuvasive.com
+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
08800322691458Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691533Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691540Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691557Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691564Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691571Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691588Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691595Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08800322691601Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861110Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861127Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861134Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861295Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861301Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861318Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861325Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861332Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861349Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861356Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861363Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861370Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861387Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861394Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861400Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861424Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861431Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861448Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861455Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861462Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974861479Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19