TSP HIP FX PLATING SYSTEMDRIVER, 5.0 HEX/3.5 HEXALOBE 14-451543

GUDID 00887868129902

Biomet Orthopedics, LLC

Bone tap, reusable
Primary Device ID00887868129902
NIH Device Record Key57e9a16e-febf-4106-8a2c-66d93a3fd83f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTSP HIP FX PLATING SYSTEMDRIVER, 5.0 HEX/3.5 HEXALOBE
Version Model Number14-451543
Catalog Number14-451543
Company DUNS129278169
Company NameBiomet Orthopedics, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887868129902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887868129902]

Moist Heat or Steam Sterilization


[00887868129902]

Moist Heat or Steam Sterilization


[00887868129902]

Moist Heat or Steam Sterilization


[00887868129902]

Moist Heat or Steam Sterilization


[00887868129902]

Moist Heat or Steam Sterilization


[00887868129902]

Moist Heat or Steam Sterilization


[00887868129902]

Moist Heat or Steam Sterilization


[00887868129902]

Moist Heat or Steam Sterilization


[00887868129902]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-26

Devices Manufactured by Biomet Orthopedics, LLC

00889024679528 - JGRKNT NEEDLES 2.9MM INLINE GD2025-01-21
00889024684317 - Juggerknot Reusable Fishmouth Guide2025-01-21
00889024685604 - Jgrknt Reusable Fishmouth Curved Perc Guide2025-01-21
00887868254451 - Comprehensive® Reverse Shoulder2024-11-21
00887868578250 - Comprehensive®2024-11-13
08428898885684 - BIPASS DISPOSABLE PUSHER2024-09-11
08428898885691 - BIPASS DISPOSABLE PUSHER2024-09-11
00880304338548 - AGC ANTERIOR FILE2024-09-11

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.