Ovation Hip Stem

GUDID 00822409010813

STD Size 2 Stem Plasma Spray

Ortho Development Corporation

Coated hip femur prosthesis, modular
Primary Device ID00822409010813
NIH Device Record Key04ab5421-8957-494f-8098-ef04a1422a46
Commercial Distribution StatusIn Commercial Distribution
Brand NameOvation Hip Stem
Version Model Number101-0002
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
GS100822409010813 [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 [Ovation Hip Stem]

00822409011216EXT Size 2 12/14 Stem Plasma Spray
00822409011186EXT Size 11 Stem Plasma Spray
00822409011179EXT Size 10 Stem Plasma Spray
00822409011162EXT Size 9 Stem Plasma Spray
00822409011155EXT Size 8 Stem Plasma Spray
00822409011148EXT Size 7 Stem Plasma Spray
00822409011131EXT Size 6 Stem Plasma Spray
00822409011124EXT Size 5 Stem Plasma Spray
00822409011117EXT Size 4 Stem Plasma Spray
00822409011100EXT Size 3 Stem Plasma Spray
00822409011094EXT Size 2 Stem Plasma Spray
00822409011087EXT Size 1 Stem Plasma Spray
00822409010912STD Size 12 Stem Plasma Spray
00822409010905STD Size 11 Stem Plasma Spray
00822409010899STD Size 10 Stem Plasma Spray
00822409010882STD Size 9 Stem Plasma Spray
00822409010875STD Size 8 Stem Plasma Spray
00822409010868STD Size 7 Stem Plasma Spray
00822409010851STD Size 6 Stem Plasma Spray
00822409010844STD Size 5 Stem Plasma Spray
00822409010837STD Size 4 Stem Plasma Spray
00822409010820STD Size 3 Stem Plasma Spray
00822409010813STD Size 2 Stem Plasma Spray
00822409010806STD Size 1 Stem Plasma Spray

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