MectaScrew PEEK

GUDID 07630040723497

Interference Screw 9x25 T25

Medacta International SA

Soft-tissue/mesh anchor, non-bioabsorbable
Primary Device ID07630040723497
NIH Device Record Key77d6d25a-a6f1-4a98-8da3-0622003f0f06
Commercial Distribution StatusIn Commercial Distribution
Brand NameMectaScrew PEEK
Version Model Number05.05.0015
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS107630040723497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-06
Device Publish Date2019-07-25

On-Brand Devices [MectaScrew PEEK]

07630040723558Interference Screw 11x35 T40
07630040723541Interference Screw 11x30 T40
07630040723534Interference Screw 10x30 T25
07630040723527Interference Screw 10x25 T25
07630040723510Interference Screw 10x20 T25
07630040723503Interference Screw 9x30 T25
07630040723497Interference Screw 9x25 T25
07630040723480Interference Screw 9x20 T25
07630040723473Interference Screw 8x30 T25
07630040723466Interference Screw 8x25 T25
07630040723459Interference Screw 8x20 T25
07630040723442Interference Screw 8x15 T25
07630040723435Interference Screw 7x30 T25
07630040723428Interference Screw 7x25 T25
07630040723411Interference Screw 7x20 T25
07630040723404Interference Screw 7x15 T25
07630040723398Interference Screw 6x25 T20
07630040723381Interference Screw 6x20 T20
07630040723374Interference Screw 6x15 T20

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