GUDID 00889024109605

Ti-locking screw, Sys4.0, TX10, 38mm

Zimmer GmbH

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00889024109605
NIH Device Record Key7f45c2cb-9ef3-40a6-9ef3-d9a809029c6c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number28.30.038
Company DUNS488133448
Company NameZimmer GmbH
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com

Device Dimensions

Length38 Millimeter
Length38 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024109605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024109605]

Moist Heat or Steam Sterilization


[00889024109605]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-29

Devices Manufactured by Zimmer GmbH

00889024593152 - Wagner Cone Prosthesis®2023-12-20
00889024593176 - Wagner Cone Prosthesis®2023-12-20
00889024593183 - Wagner Cone Prosthesis®2023-12-20
00889024593190 - Wagner Cone Prosthesis®2023-12-20
00889024593206 - Wagner Cone Prosthesis®2023-12-20
00889024593213 - Wagner Cone Prosthesis®2023-12-20
00889024593237 - Wagner Cone Prosthesis®2023-12-20
00889024593251 - Wagner Cone Prosthesis®2023-12-20

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