Stryker Resorbable Fixation System

Plate, Bone

Stryker Leibinger Micro Implants

The following data is part of a premarket notification filed by Stryker Leibinger Micro Implants with the FDA for Stryker Resorbable Fixation System.

Pre-market Notification Details

Device IDK213777
510k NumberK213777
Device Name:Stryker Resorbable Fixation System
ClassificationPlate, Bone
Applicant Stryker Leibinger Micro Implants 750 Trade Centre Way -Suite 200 Portage,  MI  49002
ContactGregory Gohl
CorrespondentGregory Gohl
Stryker Leibinger Micro Implants 750 Trade Centre Way -Suite 200 Portage,  MI  49002
Product CodeJEY  
Subsequent Product CodeGXR
Subsequent Product CodeHBW
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-03
Decision Date2022-02-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04546540337160 K213777 000
07613252009580 K213777 000
07613252009597 K213777 000
34546540337659 K213777 000
07613252727002 K213777 000
07613327123364 K213777 000
34546540337567 K213777 000
07613327177541 K213777 000
34546540337413 K213777 000
34546540337437 K213777 000
34546540337512 K213777 000
07613252645061 K213777 000
07613252713128 K213777 000
04546540337467 K213777 000
04546540337474 K213777 000
07613154991143 K213777 000
07613154629077 K213777 000
04546540337177 K213777 000
04546540337337 K213777 000
04546540337344 K213777 000
04546540337108 K213777 000
04546540337184 K213777 000
04546540337191 K213777 000
04546540337207 K213777 000
04546540337214 K213777 000
04546540337238 K213777 000
04546540337252 K213777 000
04546540337306 K213777 000
04546540337320 K213777 000
07613153066828 K213777 000
07613153066842 K213777 000
04546540337603 K213777 000
04546540337610 K213777 000
37613327405874 K213777 000
07613252256274 K213777 000
07613252448808 K213777 000
07613252645054 K213777 000
07613252713111 K213777 000
07613252726999 K213777 000
07613327123302 K213777 000
07613327123340 K213777 000
07613327177527 K213777 000
07613327543032 K213777 000
34546540337352 K213777 000
34546540337369 K213777 000
34546540337376 K213777 000
34546540337383 K213777 000
34546540337642 K213777 000
34546540337635 K213777 000
04546540337627 K213777 000
07613252528999 K213777 000
07613252529002 K213777 000
34546540337390 K213777 000
34546540337406 K213777 000
34546540337420 K213777 000
34546540337444 K213777 000
34546540337482 K213777 000
34546540337499 K213777 000
34546540337505 K213777 000
34546540337529 K213777 000
34546540337536 K213777 000
34546540337543 K213777 000
34546540337574 K213777 000
37613252477458 K213777 000

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