SIZE 71 LOCKING TIBIAL PLATE TRIAL SSI005688

GUDID 00889024584730

Biomet Orthopedics, LLC

Knee tibia prosthesis trial
Primary Device ID00889024584730
NIH Device Record Key1108d83d-cb31-4ddd-ba11-36825eae8795
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIZE 71 LOCKING TIBIAL PLATE TRIAL
Version Model NumberSSI005688
Catalog NumberSSI005688
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) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024584730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024584730]

Moist Heat or Steam Sterilization


[00889024584730]

Moist Heat or Steam Sterilization


[00889024584730]

Moist Heat or Steam Sterilization


[00889024584730]

Moist Heat or Steam Sterilization


[00889024584730]

Moist Heat or Steam Sterilization


[00889024584730]

Moist Heat or Steam Sterilization


[00889024584730]

Moist Heat or Steam Sterilization


[00889024584730]

Moist Heat or Steam Sterilization


[00889024584730]

Moist Heat or Steam Sterilization


[00889024584730]

Moist Heat or Steam Sterilization


[00889024584730]

Moist Heat or Steam Sterilization


[00889024584730]

Moist Heat or Steam Sterilization


[00889024584730]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-14
Device Publish Date2020-02-06

Devices Manufactured by Biomet Orthopedics, LLC

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
00880304368682 - BOHN MODULAR FEMORAL STEM EXTRACTOR2024-09-11

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