Encompass Hip Stem

GUDID 00822409011926

17mm Distal Centralizer

Ortho Development Corporation

Metal-on-polyethylene total hip prosthesis
Primary Device ID00822409011926
NIH Device Record Keyc6b023ed-4cec-4e7e-a6ad-f83f8e794158
Commercial Distribution StatusIn Commercial Distribution
Brand NameEncompass Hip Stem
Version Model Number106-0017
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 Diameter17 Millimeter
Outer Diameter17 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409011926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

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 [Encompass Hip Stem]

0082240901299218mm Cement Restrictor
0082240901298516mm Cement Restrictor
0082240901297814mm Cement Restrictor
0082240901296112mm Cement Restrictor
0082240901295410mm Cement Restrictor
008224090129479mm Cement Restrictor
0082240901288618mm Distal Centralizer
0082240901287917mm Distal Centralizer
0082240901286216mm Distal Centralizer
0082240901285515mm Distal Centralizer
0082240901284814mm Distal Centralizer
0082240901283113mm Distal Centralizer
0082240901282412mm Distal Centralizer
0082240901281711mm Distal Centralizer
0082240901280010mm Distal Centralizer
008224090127949mm Distal Centralizer
00822409012015EXT 12x19mm Stem Cemented
00822409012008EXT 10x17mm Stem Cemented
00822409011995EXT 8x15mm Stem Cemented
00822409011988EXT 6x13mm Stem Cemented
00822409011971STD 12x19mm Stem Cemented
00822409011964STD 10x17mm Stem Cemented
00822409011957STD 8x15mm Stem Cemented
00822409011940STD 6x13mm Stem Cemented
0082240901193318mm Distal Centralizer
0082240901192617mm Distal Centralizer
0082240901191916mm Distal Centralizer
0082240901190215mm Distal Centralizer
0082240901189614mm Distal Centralizer
0082240901188913mm Distal Centralizer
0082240901187212mm Distal Centralizer
0082240901186511mm Distal Centralizer
0082240901185810mm Distal Centralizer
008224090118419mm Distal Centralizer

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