Biolox Delta

GUDID 00822409015788

36mm -1

Ortho Development Corporation

Coated hip femur prosthesis, modular
Primary Device ID00822409015788
NIH Device Record Key61e885e2-d2bc-4fae-b391-f74823741626
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiolox Delta
Version Model Number136-3602
Company DUNS876542390
Company NameOrtho Development Corporation
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com

Device Dimensions

Outer Diameter36 Millimeter
Outer Diameter36 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409015788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-31

On-Brand Devices [Biolox Delta]

0082240901587040mm +6
0082240901586340mm +2
0082240901585640mm -1
0082240901584940mm -5
0082240901580136mm +6
0082240901579536mm +2
0082240901578836mm -1
0082240901577136mm -5
0082240901573332mm +6
0082240901572632mm +2
0082240901571932mm -1
0082240901570232mm -5
0082240901566528mm +2
0082240901565828mm -1
0082240901564128mm -5

Trademark Results [Biolox Delta]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOLOX DELTA
BIOLOX DELTA
85523572 4337105 Dead/Cancelled
CeramTec GmbH
2012-01-24
BIOLOX DELTA
BIOLOX DELTA
79376201 not registered Live/Pending
CeramTec GmbH
2023-07-11
BIOLOX DELTA
BIOLOX DELTA
79180041 5097823 Live/Registered
CeramTec GmbH
2015-10-13
BIOLOX DELTA
BIOLOX DELTA
76689704 3707260 Live/Registered
CERAMTEC GMBH
2008-05-16

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