MectaLIF Anterior System

GUDID 07630030861062

Screw Diam.5.5x40

Medacta International SA

Spinal bone screw, non-bioabsorbable
Primary Device ID07630030861062
NIH Device Record Keya5aacfa5-6581-463d-ab53-baf217cc0787
Commercial Distribution StatusIn Commercial Distribution
Brand NameMectaLIF Anterior System
Version Model Number03.30.108
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630030861062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-09
Device Publish Date2016-07-26

On-Brand Devices [MectaLIF Anterior System]

07630030875519Plate Hybrid H.18 mm
07630030875502Plate Hybrid H.16 mm
07630030875496Plate Hybrid H.14 mm
07630030875489Enhanced Screw Diam.5.5x40 (Double Packaging)
07630030875472Enhanced Screw Diam.5.5x35 (Double Packaging)
07630030875465Enhanced Screw Diam.5.5x30 (Double Packaging)
07630030875458Enhanced Screw Diam.5.5x25 (Double Packaging)
07630030875441Enhanced Screw Diam.5x40 (Double Packaging)
07630030875434Enhanced Screw Diam.5x35 (Double Packaging)
07630030875427Enhanced Screw Diam.5x30 (Double Packaging)
07630030875410Enhanced Screw Diam.5x25 (Double Packaging)
07630030875403Enhanced Screw Diam.5.5x40
07630030875397Enhanced Screw Diam.5.5x35
07630030875380Enhanced Screw Diam.5.5x30
07630030875373Enhanced Screw Diam.5.5x25
07630030875366Enhanced Screw Diam.5x40
07630030875359Enhanced Screw Diam.5x35
07630030875342Enhanced Screw Diam.5x30
07630030861109Plate Hybrid H.12 mm
07630030861093Enhanced Screw Diam.5x25
07630030861086Screw Diam.5.5x40 (Double packaging)
07630030861079Screw Diam.5x40 (Double packaging)
07630030861062Screw Diam.5.5x40
07630030861055Screw Diam.5x40
07630030834035Anterior Interbody Fusion Device 27x35x18 L15°
07630030834028Anterior Interbody Fusion Device 27x35x16 L15°
07630030834011Anterior Interbody Fusion Device 27x35x14 L15°
07630030834004Anterior Interbody Fusion Device 27x35x12 L15°
07630030833991Anterior Interbody Fusion Device 27x35x10 L15°
07630030833984Anterior Interbody Fusion Device 27x35x18 L10°
07630030833977Anterior Interbody Fusion Device 27x35x16 L10°
07630030833960Anterior Interbody Fusion Device 27x35x14 L10°
07630030833953Anterior Interbody Fusion Device 27x35x12 L10°
07630030833946Anterior Interbody Fusion Device 27x35x10 L10°
07630030833939Anterior Interbody Fusion Device 27x35x18 L5°
07630030833922Anterior Interbody Fusion Device 27x35x16 L5°
07630030833915Anterior Interbody Fusion Device 27x35x14 L5°
07630030833908Anterior Interbody Fusion Device 27x35x12 L5°
07630030833892Anterior Interbody Fusion Device 27x35x10 L5°
07630030833885Anterior Interbody Fusion Device 24x31x18 L15°
07630030833878Anterior Interbody Fusion Device 24x31x16 L15°
07630030833861Anterior Interbody Fusion Device 24x31x14 L15°
07630030833854Anterior Interbody Fusion Device 24x31x12 L15°
07630030833847Anterior Interbody Fusion Device 24x31x10 L15°
07630030833830Anterior Interbody Fusion Device 24x31x18 L10°
07630030833823Anterior Interbody Fusion Device 24x31x16 L10°
07630030833816Anterior Interbody Fusion Device 24x31x14 L10°
07630030833809Anterior Interbody Fusion Device 24x31x12 L10°
07630030833793Anterior Interbody Fusion Device 24x31x10 L10°
07630030833786Anterior Interbody Fusion Device 24x31x18 L5°
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