MectaScrew Extension

Screw, Fixation, Bone

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectascrew Extension.

Pre-market Notification Details

Device IDK203335
510k NumberK203335
Device Name:MectaScrew Extension
ClassificationScrew, Fixation, Bone
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-12
Decision Date2022-02-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630345703422 K203335 000
07630345703255 K203335 000
07630345703262 K203335 000
07630345703279 K203335 000
07630345703286 K203335 000
07630345703293 K203335 000
07630345703309 K203335 000
07630345703316 K203335 000
07630345703323 K203335 000
07630345703330 K203335 000
07630345703347 K203335 000
07630345703354 K203335 000
07630345703361 K203335 000
07630345703378 K203335 000
07630345703385 K203335 000
07630345703392 K203335 000
07630345703408 K203335 000
07630345703415 K203335 000
07630345703248 K203335 000

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