234-010-054

GUDID 04546540754547

UNIVERSAL WEDGE 8MM X 25MM (1.5MM BORE)

STRYKER CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID04546540754547
NIH Device Record Key41386ed4-00fe-446b-8634-c7efc9d1bead
Commercial Distribution StatusIn Commercial Distribution
Version Model Number234-010-054
Catalog Number234-010-054
Company DUNS187502109
Company NameSTRYKER CORPORATION
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

Customer Support Contacts

Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx
Phone+1(866)624-4422
Emailxx@xx.xx

Device Dimensions

Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length25 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104546540754547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

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 Date2015-09-09

Devices Manufactured by STRYKER CORPORATION

07613327419252 - Patient Helper2024-12-23
37613327556651 - Neptune2024-12-23 SafeAir 125mm Suction Sleeve, Non-Sterile
07613327643879 - Iconix2024-12-19 Iconix DC Guide for 2.3mm Anchor
07613327643886 - Iconix2024-12-19 Iconix DC Obturator for 2.3 Anchor
07613327644067 - Neptune2024-12-16 V2 SPECIMEN COLLECTION MANIFOLD
07613327262469 - VBOSS2024-12-10 ENDPLATE TIP SMALL
07613327262483 - VBOSS2024-12-10 ENDPLATE TIP LARGE
07613327262506 - VBOSS2024-12-10 ENDPLATE TIP OFFSET
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.