FDA.report

Modulus

Primary DI
00195377045331
Brand
Modulus
Company
Nuvasive, Inc.
Model
1460150
Device description
Modulus ALIF Bolt, Ø6.0x15mm 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
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K210271000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K210271000NuVasive Modulus ALIF SystemNu Vasive, Incorporated2021-03-01OVD

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00195377045331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00195377045331001953770453311953770453310195377045331

GMDN Terms

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
Radiation Sterilization

Contacts

PhoneEmail
+1(858)909-1800nuvainfo@globusmedical.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags

DUNS number
053950783
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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