STAYFUSE GT-IP

Screw, Fixation, Bone

PIONEER SURGICAL TECHNOLOGY

The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Stayfuse Gt-ip.

Pre-market Notification Details

Device IDK022726
510k NumberK022726
Device Name:STAYFUSE GT-IP
ClassificationScrew, Fixation, Bone
Applicant PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette,  MI  49855 -0627
ContactKathy Moran
CorrespondentKathy Moran
PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette,  MI  49855 -0627
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-16
Decision Date2002-09-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00846832009688 K022726 000
00846832009589 K022726 000
00846832009596 K022726 000
00846832009602 K022726 000
00846832009619 K022726 000
00846832009626 K022726 000
00846832009633 K022726 000
00846832009640 K022726 000
00846832009657 K022726 000
00846832009664 K022726 000
00846832009671 K022726 000
00846832009572 K022726 000

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