AXL CROSSPIN 905874

GUDID 00880304421325

Biomet Sports Medicine, LLC

Ligament bone anchor
Primary Device ID00880304421325
NIH Device Record Key76b00738-8a3b-4b13-88de-57c3878fdd3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAXL CROSSPIN
Version Model Number905874
Catalog Number905874
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
GS100880304421325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-08
Device Publish Date2015-10-24

On-Brand Devices [AXL CROSSPIN]

00880304508286907876
00880304471290907874
00880304470514907875
00880304421349905876
00880304421332905875
00880304421325905874

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