STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM

Screw, Fixation, Bone

Stryker Endoscopy

The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Bioabsorbable Interference Screw System.

Pre-market Notification Details

Device IDK993166
510k NumberK993166
Device Name:STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
ClassificationScrew, Fixation, Bone
Applicant Stryker Endoscopy 2590 WALSH AVE. Santa Clara,  CA  95051 -4085
ContactTodd Miller
CorrespondentTodd Miller
Stryker Endoscopy 2590 WALSH AVE. Santa Clara,  CA  95051 -4085
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-22
Decision Date2000-08-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04546540754752 K993166 000
04546540754585 K993166 000
04546540754592 K993166 000
04546540754608 K993166 000
04546540754615 K993166 000
04546540754622 K993166 000
04546540754639 K993166 000
04546540754738 K993166 000
04546540754745 K993166 000
04546540754578 K993166 000

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