Ovation Tribute Hip Stem

GUDID 00822409011278

EXT SIZE 6 Stem Plasma Spray

Ortho Development Corporation

Coated hip femur prosthesis, modular
Primary Device ID00822409011278
NIH Device Record Keyd8c1361a-0ff8-4808-8b57-3697e15375a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOvation Tribute Hip Stem
Version Model Number101-1306
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 Identifiers

Device Issuing AgencyDevice ID
GS100822409011278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, 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 [Ovation Tribute Hip Stem]

00822409033010EXT Size 11.5 Stem Plasma Spray
00822409033003EXT Size 10.5 Stem Plasma Spray
00822409032990STD Size 11.5 Stem Plasma Spray
00822409032983STD Size 10.5 Stem Plasma Spray
00822409011353EXT SIZE 9.5 Stem Plasma Spray
00822409011346EXT SIZE 8.5 Stem Plasma Spray
00822409011339EXT SIZE 12 Stem Plasma Spray
00822409011322EXT SIZE 11 Stem Plasma Spray
00822409011315EXT SIZE 10 Stem Plasma Spray
00822409011308EXT SIZE 9 Stem Plasma Spray
00822409011292EXT SIZE 8 Stem Plasma Spray
00822409011285EXT SIZE 7 Stem Plasma Spray
00822409011278EXT SIZE 6 Stem Plasma Spray
00822409011261EXT SIZE 5 Stem Plasma Spray
00822409011254EXT SIZE 4 Stem Plasma Spray
00822409011247EXT SIZE 3 Stem Plasma Spray
00822409011230EXT SIZE 2 Stem Plasma Spray
00822409011223EXT SIZE 1 Stem Plasma Spray
00822409011070STD SIZE 9.5 Stem Plasma Spray
00822409011063STD SIZE 8.5 Stem Plasma Spray
00822409011056STD SIZE 12 Stem Plasma Spray
00822409011049STD SIZE 11 Stem Plasma Spray
00822409011032STD SIZE 10 Stem Plasma Spray
00822409011025STD SIZE 9 Stem Plasma Spray
00822409011018STD SIZE 8 Stem Plasma Spray
00822409011001STD SIZE 7 Stem Plasma Spray
00822409010998STD SIZE 6 Stem Plasma Spray
00822409010981STD SIZE 5 Stem Plasma Spray
00822409010974STD SIZE 4 Stem Plasma Spray
00822409010967STD SIZE 3 Stem Plasma Spray
00822409010950STD SIZE 2 Stem Plasma Spray
00822409010943STD SIZE 1 Stem Plasma Spray

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