Biomet Tibial Locking Nail System SSI000229

GUDID 00880304848948

Biomet Orthopedics, LLC

Orthopaedic implant aiming arm
Primary Device ID00880304848948
NIH Device Record Key01d757b6-ff47-4ed9-9aaf-a76ebb0d53a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiomet Tibial Locking Nail System
Version Model NumberSSI000229
Catalog NumberSSI000229
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

Phone1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304848948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304848948]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2016-12-22

Devices Manufactured by Biomet Orthopedics, LLC

00887868578250 - Comprehensive®2024-11-13
08428898885684 - BIPASS DISPOSABLE PUSHER2024-09-11
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
00880304368637 - BOHN MODULAR FEMORAL STEM EXTRACTOR2024-09-11

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