SYNTHES (USA) 3.5MM CONICAL SCREWS

Screw, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 3.5mm Conical Screws.

Pre-market Notification Details

Device IDK050683
510k NumberK050683
Device Name:SYNTHES (USA) 3.5MM CONICAL SCREWS
ClassificationScrew, Fixation, Bone
Applicant SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactKathy Anderson
CorrespondentKathy Anderson
SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-17
Decision Date2005-04-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6794123170 K050683 000
H6794124190 K050683 000
H6794124210 K050683 000
H6794124230 K050683 000
H6794124240 K050683 000
H6794124250 K050683 000
H6794124260 K050683 000
H6794124270 K050683 000
H6794124280 K050683 000
H6794124290 K050683 000
H6794124300 K050683 000
H6794124170 K050683 000
H6794123310 K050683 000
H6794123190 K050683 000
H6794123210 K050683 000
H6794123230 K050683 000
H6794123240 K050683 000
H6794123250 K050683 000
H6794123260 K050683 000
H6794123270 K050683 000
H6794123280 K050683 000
H6794123290 K050683 000
H6794123300 K050683 000
H6794124310 K050683 000
H6792123170 K050683 000
H6792124190 K050683 000
H6792124210 K050683 000
H6792124230 K050683 000
H6792124240 K050683 000
H6792124250 K050683 000
H6792124260 K050683 000
H6792124270 K050683 000
H6792124280 K050683 000
H6792124290 K050683 000
H6792124300 K050683 000
H6792124170 K050683 000
H6792123310 K050683 000
H6792123190 K050683 000
H6792123210 K050683 000
H6792123230 K050683 000
H6792123240 K050683 000
H6792123250 K050683 000
H6792123260 K050683 000
H6792123270 K050683 000
H6792123280 K050683 000
H6792123290 K050683 000
H6792123300 K050683 000
H6792124310 K050683 000

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