FDA.report

MectaLIF 3D

Primary DI
07630542736797
Brand
MectaLIF 3D
Company
Medacta International SA
Model
03.43.081
Device description
MectaLIF Oblique 3D 10x32x7 L5°
Published
2025-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K251016000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K251016000MectaLIF 3D MetalMedacta International S.A.2025-07-17MAX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630542736797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630542736797076305427367977630542736797

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 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
488227125
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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