ALLTHREAD TITANIUM 902598

GUDID 00880304453463

Biomet Sports Medicine, LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00880304453463
NIH Device Record Keyc7e0ed6b-6a33-4507-9890-2c222bd58f66
Commercial Distribution StatusIn Commercial Distribution
Brand NameALLTHREAD TITANIUM
Version Model Number902598
Catalog Number902598
Company DUNS627100159
Company NameBiomet Sports Medicine, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304453463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-21
Device Publish Date2015-10-24

Devices Manufactured by Biomet Sports Medicine, LLC

00880304460454 - MAXFIRE2020-05-06
00880304475915 - MAXFIRE MARXMEN2020-05-06
00880304475922 - MAXFIRE MARXMEN2020-05-06
00880304477193 - JUGGERKNOT SOFT ANCHORS2020-02-06
00880304477315 - JUGGERKNOT SOFT ANCHORS2020-02-06
00880304508590 - JUGGERKNOT SOFT ANCHORS2020-02-06
00880304509627 - JUGGERKNOT SOFT ANCHORS2020-02-06
00880304511699 - JUGGERKNOT SOFT ANCHORS2020-02-06

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