ACDF Stand Alone Cervical

GUDID 07630040726320

Mecta-C SA – Plate Hybrid Lag h6

Medacta International SA

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device ID07630040726320
NIH Device Record Keye9ee7ae0-9392-4405-9bfe-67bfa09fa938
Commercial Distribution StatusIn Commercial Distribution
Brand NameACDF Stand Alone Cervical
Version Model Number03.18.516
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
GS107630040726320 [Primary]
GS107630040726320 [Primary]
GS107630040726320 [Primary]
GS107630040726320 [Primary]
GS107630040726320 [Primary]
GS107630040726320 [Primary]
GS107630040726320 [Primary]
GS107630040726320 [Primary]
GS107630040726320 [Primary]
GS107630040726320 [Primary]
GS107630040726320 [Primary]
GS107630040726320 [Primary]
GS107630040726320 [Primary]
GS107630040726320 [Primary]
GS107630040726320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [ACDF Stand Alone Cervical]

07630040726368Mecta-C SA – Plate Hybrid Lag h10
07630040726351Mecta-C SA – Plate Hybrid Lag h9
07630040726344Mecta-C SA – Plate Hybrid Lag h8
07630040726337Mecta-C SA – Plate Hybrid Lag h7
07630040726320Mecta-C SA – Plate Hybrid Lag h6
07630040724739Mecta-C SA PEEK Cage 15x13x5x7°
07630040725729Mecta-C SA TiPEEK Cage 18x15x6x7°
07630040725712Mecta-C SA TiPEEK Cage 18x15x5x7°
07630040725705Mecta-C SA TiPEEK Cage 16x14x12x7°
07630040725699Mecta-C SA TiPEEK Cage 16x14x11x7°
07630040725682Mecta-C SA TiPEEK Cage 16x14x10x7°
07630040725675Mecta-C SA TiPEEK Cage 16x14x9x7°
07630040725668Mecta-C SA TiPEEK Cage 16x14x8x7°
07630040725651Mecta-C SA TiPEEK Cage 16x14x7x7°
07630040725644Mecta-C SA TiPEEK Cage 16x14x6x7°
07630040725637Mecta-C SA TiPEEK Cage 16x14x5x7°
07630040725620Mecta-C SA TiPEEK Cage 15x13x12x7°
07630040725613Mecta-C SA TiPEEK Cage 15x13x11x7°
07630040725606Mecta-C SA TiPEEK Cage 15x13x10x7°
07630040725590Mecta-C SA TiPEEK Cage 15x13x9x7°
07630040725583Mecta-C SA TiPEEK Cage 15x13x8x7°
07630040725576Mecta-C SA TiPEEK Cage 15x13x7x7°
07630040725569Mecta-C SA TiPEEK Cage 15x13x6x7°
07630040725552Mecta-C SA TiPEEK Cage 15x13x5x7°
07630040725545Mecta-C SA PEEK Cage 18x15x12x7°
07630040725538Mecta-C SA PEEK Cage 18x15x11x7°
07630971240803Mecta-C SA Antibackout Trio h9-h12
07630971240797Mecta-C SA Antibackout Trio h7-h8
07630971238282Mecta-C SA Antibackout Hybrid
07630971238275Mecta-C SA Antibackout Quattro h9-h12
07630971238268Mecta-C SA Antibackout Quattro h5-h8
07630971238251Mecta-C SA Antibackout Trio h5-h6
07630971238244Mecta-C SA Antibackout Flush h9-h12
07630971238237Mecta-C SA Antibackout Flush h6-h8
07630040732390Mecta-C SA Tap Screw Lag Ø4.2x22 (2x)
07630040732383Mecta-C SA Tap Screw Lag Ø3.8x22 (2x)
07630040732376Mecta-C SA Tap Screw Lock Ø4.2x22 (2x)
07630040732369Mecta-C SA Tap Screw Lock Ø3.8x22 (2x)
07630040732352Mecta-C SA Tap Screw Lag Ø4.2x22 (1x)
07630040732345Mecta-C SA Tap Screw Lag Ø3.8x22 (1x)
07630040732338Mecta-C SA Tap Screw Lock Ø4.2x22 (1x)
07630040732321Mecta-C SA Tap Screw Lock Ø3.8x22 (1x)
07630040727181Mecta-C SA Tap Screw Lag Ø4.2x20 (2x)
07630040727174Mecta-C SA Tap Screw Lag Ø4.2x18 (2x)
07630040727167Mecta-C SA Tap Screw Lag Ø4.2x16 (2x)
07630040727150Mecta-C SA Tap Screw Lag Ø4.2x14 (2x)
07630040727143Mecta-C SA Tap Screw Lag Ø4.2x12 (2x)
07630040727136Mecta-C SA Tap Screw Lag Ø3.8x20 (2x)
07630040727129Mecta-C SA Tap Screw Lag Ø3.8x18 (2x)
07630040727112Mecta-C SA Tap Screw Lag Ø3.8x16 (2x)

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