Series A Asymmetrical Patella SSI000241

GUDID 00880304849501

Biomet Orthopedics, LLC

Surgical drill guide, reusable
Primary Device ID00880304849501
NIH Device Record Keyd113446c-c690-45c4-bd33-31835e0a406c
Commercial Distribution Discontinuation2016-10-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSeries A Asymmetrical Patella
Version Model NumberSSI000241
Catalog NumberSSI000241
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 Dimensions

Outer Diameter28 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304849501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304849501]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2016-10-04

On-Brand Devices [Series A Asymmetrical Patella]

00880304849549SSI000245
00880304849532SSI000244
00880304849525SSI000243
00880304849518SSI000242
00880304849501SSI000241
00880304849495SSI000240

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