spongiosa screw flat head

GUDID 04048844006365

implantcast GmbH

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID04048844006365
NIH Device Record Keyd885c2a9-d9bb-4ae5-a82d-e0a731e1f5f8
Commercial Distribution StatusIn Commercial Distribution
Brand Namespongiosa screw flat head
Version Model Number02801020
Company DUNS324369826
Company Nameimplantcast GmbH
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 Datetrue
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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104048844006365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, 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 Date2017-10-31

On-Brand Devices [spongiosa screw flat head]

0404884400643302801055
0404884400642602801050
0404884400641902801045
0404884400640202801040
0404884400639602801035
0404884400638902801030
0404884400637202801025
0404884400636502801020
0404884400635802801015

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.