234-010-051

GUDID 04546540754516

UNIVERSAL WEDGE 7MM X 20MM (1.5MM BORE)

STRYKER CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID04546540754516
NIH Device Record Keyffc3b96a-872d-4cdc-8c04-ca1f73f265d0
Commercial Distribution StatusIn Commercial Distribution
Version Model Number234-010-051
Catalog Number234-010-051
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

Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter
Device Size Text, specify0
Length20 Millimeter
Lumen/Inner Diameter1.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104546540754516 [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

37613327576802 - PELLO2024-11-21 4mm Angled 15 Degree Diamond Bur
37613327576826 - PELLO2024-11-21 4mm Angled 70 Degree Diamond Bur
07613327579031 - PELLO2024-11-21 4mm Angled 15 Degree Diamond Bur
07613327579055 - PELLO2024-11-21 4mm Angled 70 Degree Diamond Bur
07613327261820 - MAC2024-10-29 SCREWDRIVER
07613327271089 - DYNATRAN2024-10-29 COMPRESSOR
07613327273885 - Aero-LL2024-10-29 INSERTER - DISTRACTOR
37613327566162 - Neptune2024-10-23 V2 SPECIMEN COLLECTION MANIFOLD KIT

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