234-010-083

GUDID 04546540754783

TUNNEL NOTCHER BIOABSORBABLE ACL SCREW

STRYKER CORPORATION

Orthopaedic bone screw starter/notcher
Primary Device ID04546540754783
NIH Device Record Keyeef066c4-9922-49ae-9f72-a7ff1f2898c8
Commercial Distribution StatusIn Commercial Distribution
Version Model Number234-010-083
Catalog Number234-010-083
Company DUNS187502109
Company NameSTRYKER CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104546540754783 [Primary]

FDA Product Code

HWDSTARTER, BONE SCREW

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04546540754783]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-08-31

Devices Manufactured by STRYKER CORPORATION

07613327482706 - N/A2025-05-08 System 9 Transfer Shield, Small
07613327163278 - NA2025-04-28
07613327601138 - OptaBlate2025-04-25 Curve 10mm Probe Single Kit
07613327601145 - OptaBlate2025-04-25 Curve 20mm Probe Single Kit
07613327601152 - OptaBlate2025-04-25 Curve 15mm Probe Single Kit
07613327631883 - OptaBlate2025-04-25 Straight 10MM Probe Dual Kit
07613327631890 - OptaBlate2025-04-25 Straight 10MM Probe Single Kit
07613327626391 - ThermaClear2025-04-14

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.