Alpine Hip System

GUDID 00822409000036

STD Size 11 Stem Press-Fit

Ortho Development Corporation

Coated femoral stem prosthesis, modular
Primary Device ID00822409000036
NIH Device Record Key037d8c8c-f0b9-4ecd-b748-cd963850f668
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlpine Hip System
Version Model Number700-0011
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
GS100822409000036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or 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 [Alpine Hip System]

00822409000258EXT Size 20 Stem Press-Fit
00822409000241EXT Size 19 Stem Press-Fit
00822409000234EXT Size 18 Stem Press-Fit
00822409000227EXT Size 17 Stem Press-Fit
00822409000210EXT Size 16 Stem Press-Fit
00822409000203EXT Size 15 Stem Press-Fit
00822409000197EXT Size 14 Stem Press-Fit
00822409000180EXT Size 13 Stem Press-Fit
00822409000173EXT Size 12 Stem Press-Fit
00822409000166EXT Size 11 Stem Press-Fit
00822409000159EXT Size 10 Stem Press-Fit
00822409000142EXT Size 9 Stem Press-Fit
00822409000128STD Size 20 Stem Press-Fit
00822409000111STD Size 19 Stem Press-Fit
00822409000104STD Size 18 Stem Press-Fit
00822409000098STD Size 17 Stem Press-Fit
00822409000081STD Size 16 Stem Press-Fit
00822409000074STD Size 15 Stem Press-Fit
00822409000067STD Size 14 Stem Press-Fit
00822409000050STD Size 13 Stem Press-Fit
00822409000043STD Size 12 Stem Press-Fit
00822409000036STD Size 11 Stem Press-Fit
00822409000029STD Size 10 Stem Press-Fit
00822409000012STD Size 9 Stem Press-Fit

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