Restoration ADM X3 Insert 7236-2-850

GUDID 07613327316018

Restoration ADM X3 Insert

Howmedica Osteonics Corp.

Non-constrained polyethylene acetabular liner
Primary Device ID07613327316018
NIH Device Record Key8e6e8a5b-00d1-4975-9923-749f39dcbfee
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestoration ADM X3 Insert
Version Model Number7236-2-850
Catalog Number7236-2-850
Company DUNS058311945
Company NameHowmedica Osteonics Corp.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter44 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327316018 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-20
Device Publish Date2019-11-12

On-Brand Devices [Restoration ADM X3 Insert]

07613327316032Restoration ADM X3 Insert
07613327316025Restoration ADM X3 Insert
07613327316018Restoration ADM X3 Insert
07613327315950Restoration ADM X3 Insert

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