FDA.reportPublic FDA data

Modulus Expandable

Primary DI
00195377056238
Brand
Modulus Expandable
Company
Nuvasive, Inc.
Model
5088600P2
Device description
MOD-EX XLIF, 8x18x60mm 0-15°
Published
2023-08-10
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
MAXIntervertebral fusion device with bone graft, lumbar
MQVFILLER, BONE VOID, CALCIUM COMPOUND
OVDIntervertebral fusion device with integrated fixation, lumbar
PHMIntervertebral fusion device with bone graft, thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2
PHMIntervertebral Fusion Device With Bone Graft, ThoracicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220478000NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated2022-06-21MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195377056238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195377056238001953770562381953770562380195377056238

Sterilization Methods#

Method table
Method
Radiation 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
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
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