M-Fix 4mm

GUDID 00860366001413

The M-Fix is designed to provide reduction and stabilization of the acromioclavicular joint while providing a simpler, streamlined surgical technique.

CORACOID SOLUTIONS LLC

Acromioclavicular joint stabilization implant
Primary Device ID00860366001413
NIH Device Record Keyc241cdf8-be0d-480b-ba45-7b7c2f281481
Commercial Distribution StatusIn Commercial Distribution
Brand NameM-Fix 4mm
Version Model NumberFG3004
Company DUNS073670228
Company NameCORACOID SOLUTIONS LLC
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860366001413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTNWasher, Bolt Nut

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-19
Device Publish Date2018-06-18

Devices Manufactured by CORACOID SOLUTIONS LLC

00860366001406 - J-Pass Suture Passer2020-02-06 Suture passer used for passing suture around boney structures.
00860366001413 - M-Fix 4mm2018-07-19The M-Fix is designed to provide reduction and stabilization of the acromioclavicular joint while providing a simpler, streamlined surgical technique.
00860366001413 - M-Fix 4mm2018-07-19 The M-Fix is designed to provide reduction and stabilization of the acromioclavicular joint while providing a simpler, streamlin
00860366001420 - M-Fix 7mm2018-07-19 Surgical implant to reduce and stabilize the acromioclavicular joint.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.