SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS

Screw, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 4.0 And 5.0 Mm Locking Screws.

Pre-market Notification Details

Device IDK000089
510k NumberK000089
Device Name:SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
ClassificationScrew, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactBonnie J Smith
CorrespondentBonnie J Smith
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-12
Decision Date2000-02-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H67904005590S0 K000089 000
H679458940S0 K000089 000
H6794589420 K000089 000
H679458942S0 K000089 000
H6794589440 K000089 000
H679458944S0 K000089 000
H6794589460 K000089 000
H679458946S0 K000089 000
H6794589480 K000089 000
H679458948S0 K000089 000
H6794589500 K000089 000
H679458950S0 K000089 000
H6794589520 K000089 000
H679458952S0 K000089 000
H6794589400 K000089 000
H679458938S0 K000089 000
H6794589260 K000089 000
H679458926S0 K000089 000
H6794589280 K000089 000
H679458928S0 K000089 000
H6794589300 K000089 000
H679458930S0 K000089 000
H6794589320 K000089 000
H679458932S0 K000089 000
H6794589340 K000089 000
H679458934S0 K000089 000
H6794589360 K000089 000
H679458936S0 K000089 000
H6794589380 K000089 000
H6794589540 K000089 000
H679458954S0 K000089 000
H6794589560 K000089 000
H6794589850 K000089 000
H679458985S0 K000089 000
H6794589900 K000089 000
H679458990S0 K000089 000
H6794589950 K000089 000
H679458995S0 K000089 000
H6794589990 K000089 000
H679458999S0 K000089 000
H679040054080 K000089 000
H67904005408S0 K000089 000
H679040054100 K000089 000
H67904005410S0 K000089 000
H679040054120 K000089 000
H679458980S0 K000089 000
H6794589800 K000089 000
H679458956S0 K000089 000
H6794589580 K000089 000
H679458958S0 K000089 000
H6794589600 K000089 000
H679458960S0 K000089 000
H6794589640 K000089 000
H679458964S0 K000089 000
H6794589680 K000089 000
H679458968S0 K000089 000
H6794589720 K000089 000
H679458972S0 K000089 000
H6794589760 K000089 000
H679458976S0 K000089 000
H67904005412S0 K000089 000
H679040055900 K000089 000
H679040055160 K000089 000
H679040055320 K000089 000
H67904005532S0 K000089 000
H679040055340 K000089 000
H67904005534S0 K000089 000
H679040055360 K000089 000
H67904005536S0 K000089 000
H679040055380 K000089 000
H67904005538S0 K000089 000
H679040055400 K000089 000
H67904005540S0 K000089 000
H679040055420 K000089 000
H67904005542S0 K000089 000
H67904005544S0 K000089 000
H67904005530S0 K000089 000
H679040055300 K000089 000
H67904005516S0 K000089 000
H679040055180 K000089 000
H67904005518S0 K000089 000
H679040055200 K000089 000
H67904005520S0 K000089 000
H679040055220 K000089 000
H67904005522S0 K000089 000
H679040055240 K000089 000
H67904005524S0 K000089 000
H679040055260 K000089 000
H67904005526S0 K000089 000
H679040055280 K000089 000
H67904005528S0 K000089 000
H679040055460 K000089 000
H67904005546S0 K000089 000
H679040055480 K000089 000
H679040055640 K000089 000
H67904005564S0 K000089 000
H679040055660 K000089 000
H67904005566S0 K000089 000
H679040055680 K000089 000
H67904005568S0 K000089 000
H679040055700 K000089 000
H67904005570S0 K000089 000
H679040055750 K000089 000
H67904005575S0 K000089 000
H679040055800 K000089 000
H67904005580S0 K000089 000
H679040055850 K000089 000
H67904005562S0 K000089 000
H679040055620 K000089 000
H67904005548S0 K000089 000
H679040055500 K000089 000
H67904005550S0 K000089 000
H679040055520 K000089 000
H67904005552S0 K000089 000
H679040055540 K000089 000
H67904005554S0 K000089 000
H679040055560 K000089 000
H67904005556S0 K000089 000
H679040055580 K000089 000
H67904005558S0 K000089 000
H679040055600 K000089 000
H67904005560S0 K000089 000
H67904005585S0 K000089 000
H6794588220 K000089 000
H6794588380 K000089 000
H679458838S0 K000089 000
H6794588400 K000089 000
H679458840S0 K000089 000
H6794588420 K000089 000
H679458842S0 K000089 000
H6794588440 K000089 000
H679458844S0 K000089 000
H6794588460 K000089 000
H679458846S0 K000089 000
H6794588480 K000089 000
H679458848S0 K000089 000
H6794588500 K000089 000
H679458836S0 K000089 000
H6794588360 K000089 000
H679458822S0 K000089 000
H6794588240 K000089 000
H679458824S0 K000089 000
H6794588260 K000089 000
H679458826S0 K000089 000
H6794588280 K000089 000
H679458828S0 K000089 000
H6794588300 K000089 000
H679458830S0 K000089 000
H6794588320 K000089 000
H679458832S0 K000089 000
H6794588340 K000089 000
H679458834S0 K000089 000
H679458850S0 K000089 000
H6794588520 K000089 000
H679458852S0 K000089 000
H679458868S0 K000089 000
H6794588700 K000089 000
H679458870S0 K000089 000
H6794588720 K000089 000
H679458872S0 K000089 000
H6794588740 K000089 000
H679458874S0 K000089 000
H6794588760 K000089 000
H679458876S0 K000089 000
H6794588780 K000089 000
H679458878S0 K000089 000
H6794588800 K000089 000
H679458880S0 K000089 000
H6794588680 K000089 000
H679458866S0 K000089 000
H6794588540 K000089 000
H679458854S0 K000089 000
H6794588560 K000089 000
H679458856S0 K000089 000
H6794588580 K000089 000
H679458858S0 K000089 000
H6794588600 K000089 000
H679458860S0 K000089 000
H6794588620 K000089 000
H679458862S0 K000089 000
H6794588640 K000089 000
H679458864S0 K000089 000
H6794588660 K000089 000
H679040055440 K000089 000
H679458820S0 K000089 000
H679040054140 K000089 000
H679040054300 K000089 000
H67904005430S0 K000089 000
H679040054320 K000089 000
H67904005432S0 K000089 000
H679040054340 K000089 000
H67904005434S0 K000089 000
H679040054360 K000089 000
H67904005436S0 K000089 000
H679040054380 K000089 000
H67904005438S0 K000089 000
H679040054400 K000089 000
H67904005440S0 K000089 000
H679040054420 K000089 000
H67904005428S0 K000089 000
H679040054280 K000089 000
H67904005414S0 K000089 000
H679040054160 K000089 000
H67904005416S0 K000089 000
H679040054180 K000089 000
H67904005418S0 K000089 000
H679040054200 K000089 000
H67904005420S0 K000089 000
H679040054220 K000089 000
H67904005422S0 K000089 000
H679040054240 K000089 000
H67904005424S0 K000089 000
H679040054260 K000089 000
H67904005426S0 K000089 000
H67904005442S0 K000089 000
H679040054440 K000089 000
H67904005444S0 K000089 000
H67904005460S0 K000089 000
H679040054620 K000089 000
H67904005462S0 K000089 000
H679040054640 K000089 000
H67904005464S0 K000089 000
H679040054660 K000089 000
H67904005466S0 K000089 000
H679040054680 K000089 000
H67904005468S0 K000089 000
H679040054700 K000089 000
H67904005470S0 K000089 000
H6794588180 K000089 000
H679458818S0 K000089 000
H679040054600 K000089 000
H67904005458S0 K000089 000
H679040054460 K000089 000
H67904005446S0 K000089 000
H679040054480 K000089 000
H67904005448S0 K000089 000
H679040054500 K000089 000
H67904005450S0 K000089 000
H679040054520 K000089 000
H67904005452S0 K000089 000
H679040054540 K000089 000
H67904005454S0 K000089 000
H679040054560 K000089 000
H67904005456S0 K000089 000
H679040054580 K000089 000
H6794588200 K000089 000
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.