PCA 6299-H-428

GUDID 07613327138689

Constrained Acetabular Insert

Howmedica Osteonics Corp.

Constrained polyethylene acetabular liner
Primary Device ID07613327138689
NIH Device Record Key3b8a582a-9749-4bb9-80b4-f08e9aee5327
Commercial Distribution StatusIn Commercial Distribution
Brand NamePCA
Version Model Number6299-H-428
Catalog Number6299-H-428
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 Dimensions

Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter28 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327138689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

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

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07613327138276Skirted 2 Degree 52' Taper Head
07613327138252Constrained Acetabular Insert

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