Dome Hole Plug 2060-0000-1

GUDID 07613327037067

Acetabular Dome Hole Plug

Howmedica Osteonics Corp.

Acetabulum prosthesis hole plug
Primary Device ID07613327037067
NIH Device Record Key409787bb-b1a6-44a9-9d04-5d0ca01c3a01
Commercial Distribution StatusIn Commercial Distribution
Brand NameDome Hole Plug
Version Model Number2060-0000-1
Catalog Number2060-0000-1
Company DUNS058311945
Company NameHowmedica Osteonics Corp.
Device Count1
DM Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327037067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDLProsthesis, hip, semi-constrained (metal cemented acetabular component)

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 Date2015-09-24

Devices Manufactured by Howmedica Osteonics Corp.

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07613327524628 - TRIATHLON2025-09-02 Hinge Small Proximal Tibial Bearing Component
07613327538458 - INSTRUMENT2025-09-02 Hinge Trial Bearing Plate
07613327639544 - TRIATHLON2025-09-02 End Cap
07613327659948 - INSTRUMENT2025-09-02 Hinge Tibial Bearing Post Trial
07613327659955 - INSTRUMENT2025-09-02 Hinge Tibial Bearing Post Trial
07613327668896 - Modular Elbow2025-03-04 Axle Pin Assembly Large Elbow

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