FDA.reportPublic FDA data

MectaLIF 3D Metal Anterior

Primary DI
07630542763809
Brand
MectaLIF 3D Metal Anterior
Company
Medacta International SA
Model
03.38.007
Device description
MectaLIF Anterior 3D Printed Cage 24x31x12x10°
Published
2026-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K254202000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254202000MectaLIF 3D Metal AnteriorMedacta International S.A.2026-05-05OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630542763809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542763809076305427638097630542763809

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 typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped 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 packaged with the cage.

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630971230156Spine Instruments03.30.10.20372026-05-12
07630971236745Spine Instruments03.30.10.20382026-05-12
07630971236752Spine Instruments03.30.10.20392026-05-12
07630971236769Spine Instruments03.30.10.20402026-05-12
07630971236776Spine Instruments03.30.10.20412026-05-12
07630971236783Spine Instruments03.30.10.20422026-05-12
07630971236790Spine Instruments03.30.10.20432026-05-12
07630971236806Spine Instruments03.30.10.20442026-05-12
07630971236813Spine Instruments03.30.10.20452026-05-12
07630971236820Spine Instruments03.30.10.20462026-05-12
07630542763748MectaLIF 3D Metal Anterior03.38.0012026-05-08
07630542763755MectaLIF 3D Metal Anterior03.38.0022026-05-08
07630542763762MectaLIF 3D Metal Anterior03.38.0032026-05-08
07630542763779MectaLIF 3D Metal Anterior03.38.0042026-05-08
07630542763786MectaLIF 3D Metal Anterior03.38.0052026-05-08
07630542763793MectaLIF 3D Metal Anterior03.38.0062026-05-08
07630542763816MectaLIF 3D Metal Anterior03.38.0082026-05-08
07630542763823MectaLIF 3D Metal Anterior03.38.0092026-05-08
07630542763830MectaLIF 3D Metal Anterior03.38.0102026-05-08
07630542763847MectaLIF 3D Metal Anterior03.38.0112026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613153046196AVS PLStryker CorporationOVD2015-09-14
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07613153046363AVS PLStryker CorporationOVD2015-09-14
07613153046370AVS PLStryker CorporationOVD2015-09-14
07613153046400AVS TLStryker CorporationOVD2015-09-14
07613153046417AVS TLStryker CorporationOVD2015-09-14
07613153046431AVS TLStryker CorporationOVD2015-09-14
07613153046448AVS TLStryker CorporationOVD2015-09-14
07613153046455AVS TLStryker CorporationOVD2015-09-14
07613153046516AVS TLStryker CorporationOVD2015-09-14
07613153046523AVS TLStryker CorporationOVD2015-09-14
07613153046554AVS TLStryker CorporationOVD2015-09-14
07613153046561AVS TLStryker CorporationOVD2015-09-14
07613153046578AVS TLStryker CorporationOVD2015-09-14
07613153046585AVS TLStryker CorporationOVD2015-09-14
07613153046592AVS TLStryker CorporationOVD2015-09-14
07613153046608AVS TLStryker CorporationOVD2015-09-14
07613153046615AVS TLStryker CorporationOVD2015-09-14
07613153046622AVS TLStryker CorporationOVD2015-09-14
07613153046639AVS TLStryker CorporationOVD2015-09-14
07613153046646AVS TLStryker CorporationOVD2015-09-14
07613153046653AVS TLStryker CorporationOVD2015-09-14
07613153046660AVS TLStryker CorporationOVD2015-09-14
07613153046677AVS TLStryker CorporationOVD2015-09-14
07613153046691AVS TLStryker CorporationOVD2015-09-14