623009

GUDID 04546540097897

BOS Plate

Stryker Trauma SA

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID04546540097897
NIH Device Record Key90f1815d-e651-44f7-89fe-de89bfee74eb
Commercial Distribution StatusIn Commercial Distribution
Version Model Number623009
Catalog Number623009
Company DUNS481999654
Company NameStryker Trauma SA
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
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter
Device Size Text, specify0
Length82 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104546540097897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


[04546540097897]

Moist Heat or Steam Sterilization


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 Stryker Trauma SA

07613327605808 - PANGEA2024-10-18 Small Frag. Proximal Tibia Targeter Tray
07613327603101 - REUNION2024-10-09 Modular Glenoid Surface Trial
07613327603118 - REUNION2024-10-09 Modular Glenoid Surface Trial
07613327603125 - REUNION2024-10-09 Modular Glenoid Surface Trial
07613327603132 - REUNION2024-10-09 Modular Humeral Head Trial
07613327603149 - REUNION2024-10-09 Modular Glenoid Surface Trial
07613327603156 - REUNION2024-10-09 Modular Humeral Head Trial
07613327603163 - REUNION2024-10-09 Modular Glenoid Surface Trial

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