TSP HIP FX PLATING SYSTEM3.5MM HEX DRIVER, NECK SHAFT 14-451531

GUDID 00887868130014

Biomet Orthopedics, LLC

Orthopaedic implant/instrument adaptor, reusable
Primary Device ID00887868130014
NIH Device Record Key6232bfcc-8c8b-4a5e-b599-49ab752d02a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameTSP HIP FX PLATING SYSTEM3.5MM HEX DRIVER, NECK SHAFT
Version Model Number14-451531
Catalog Number14-451531
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
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 Dimensions

Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS100887868130014 [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

[00887868130014]

Moist Heat or Steam Sterilization


[00887868130014]

Moist Heat or Steam Sterilization


[00887868130014]

Moist Heat or Steam Sterilization


[00887868130014]

Moist Heat or Steam Sterilization


[00887868130014]

Moist Heat or Steam Sterilization


[00887868130014]

Moist Heat or Steam Sterilization


[00887868130014]

Moist Heat or Steam Sterilization


[00887868130014]

Moist Heat or Steam Sterilization


[00887868130014]

Moist Heat or Steam Sterilization


[00887868130014]

Moist Heat or Steam Sterilization


[00887868130014]

Moist Heat or Steam Sterilization


[00887868130014]

Moist Heat or Steam Sterilization


[00887868130014]

Moist Heat or Steam Sterilization


[00887868130014]

Moist Heat or Steam Sterilization


[00887868130014]

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

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08428898885691 - BIPASS DISPOSABLE PUSHER2024-09-11
00880304338548 - AGC ANTERIOR FILE2024-09-11
00880304339224 - PARALLEL PULLER2024-09-11
00880304342187 - AGC MODULAR TIBIAL II2024-09-11
00880304365247 - BIO-MODULAR2024-09-11

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