SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Large Fragment Dynamic Compression Locking (dcl) System.

Pre-market Notification Details

Device IDK000682
510k NumberK000682
Device Name:SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-29
Decision Date2000-05-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6794133800 K000682 000
H6794246010 K000682 000
H6794246110 K000682 000
H6794246210 K000682 000
H6794246310 K000682 000
H6794246410 K000682 000
H6794246510 K000682 000
H6794246610 K000682 000
H6794246810 K000682 000
H6794247010 K000682 000
H6794245910 K000682 000
H6794245810 K000682 000
H6794133850 K000682 000
H6794133900 K000682 000
H6794134260 K000682 000
H6794245210 K000682 000
H6794245310 K000682 000
H6794245410 K000682 000
H6794245510 K000682 000
H6794245610 K000682 000
H6794245710 K000682 000
H6794247210 K000682 000
H6794265610 K000682 000
H6794265710 K000682 000
H679426642S0 K000682 000
H6794266520 K000682 000
H679426652S0 K000682 000
H6794266610 K000682 000
H6794266620 K000682 000
H679426662S0 K000682 000
H6794266720 K000682 000
H679426672S0 K000682 000
H6794266810 K000682 000
H6794266420 K000682 000
H6794266410 K000682 000
H6794265810 K000682 000
H6794265910 K000682 000
H6794266010 K000682 000
H6794266110 K000682 000
H6794266210 K000682 000
H6794266220 K000682 000
H679426622S0 K000682 000
H6794266320 K000682 000
H679426632S0 K000682 000
H6794266820 K000682 000
H6794133750 K000682 000
H6794122010 K000682 000
H6794122130 K000682 000
H6794122140 K000682 000
H6794122150 K000682 000
H6794122160 K000682 000
H6794122170 K000682 000
H6794122180 K000682 000
H6794122190 K000682 000
H6794122200 K000682 000
H6794122210 K000682 000
H6794122120 K000682 000
H6794122110 K000682 000
H6794122020 K000682 000
H6794122030 K000682 000
H6794122040 K000682 000
H6794122050 K000682 000
H6794122060 K000682 000
H6794122070 K000682 000
H6794122080 K000682 000
H6794122090 K000682 000
H6794122100 K000682 000
H6794122220 K000682 000
H6794122230 K000682 000
H6794122240 K000682 000
H6794133400 K000682 000
H6794133420 K000682 000
H6794133440 K000682 000
H6794133460 K000682 000
H6794133480 K000682 000
H6794133500 K000682 000
H6794133550 K000682 000
H6794133600 K000682 000
H6794133650 K000682 000
H6794133380 K000682 000
H6794133360 K000682 000
H6794122250 K000682 000
H6794122260 K000682 000
H6794122270 K000682 000
H6794133240 K000682 000
H6794133260 K000682 000
H6794133280 K000682 000
H6794133300 K000682 000
H6794133320 K000682 000
H6794133340 K000682 000
H6794133700 K000682 000
H679426682S0 K000682 000
H6792134650 K000682 000
H6792246110 K000682 000
H6792246210 K000682 000
H6792246410 K000682 000
H6792246610 K000682 000
H6792246810 K000682 000
H6792247010 K000682 000
H6792247210 K000682 000
H6792265610 K000682 000
H6792265710 K000682 000
H6792246010 K000682 000
H6792245910 K000682 000
H6792134750 K000682 000
H6792134850 K000682 000
H6792245210 K000682 000
H6792245310 K000682 000
H6792245410 K000682 000
H6792245510 K000682 000
H6792245610 K000682 000
H6792245710 K000682 000
H6792245810 K000682 000
H6792265810 K000682 000
H6792265910 K000682 000
H6792266010 K000682 000
H6792266620 K000682 000
H679226662S0 K000682 000
H6792266720 K000682 000
H679226672S0 K000682 000
H6792266810 K000682 000
H6792266820 K000682 000
H679226682S0 K000682 000
H6792267010 K000682 000
H6792267210 K000682 000
H6792266610 K000682 000
H679226652S0 K000682 000
H6792266110 K000682 000
H6792266210 K000682 000
H6792266220 K000682 000
H679226622S0 K000682 000
H679226632S0 K000682 000
H6792266410 K000682 000
H6792266420 K000682 000
H679226642S0 K000682 000
H6792266520 K000682 000
H6794134750 K000682 000
H6792134550 K000682 000
H6794267010 K000682 000
10886982275462 K000682 000
10886982275479 K000682 000
10886982275486 K000682 000
H6792122010 K000682 000
H6792122020 K000682 000
H6792122030 K000682 000
H6792122040 K000682 000
H6792122050 K000682 000
H6792122060 K000682 000
10886982275455 K000682 000
10886982275448 K000682 000
H6794267210 K000682 000
10886982275363 K000682 000
10886982275370 K000682 000
10886982275387 K000682 000
10886982275394 K000682 000
10886982275400 K000682 000
10886982275417 K000682 000
10886982275424 K000682 000
10886982275431 K000682 000
H6792122070 K000682 000
H6792122080 K000682 000
H6792122090 K000682 000
H6792122210 K000682 000
H6792122220 K000682 000
H6792122230 K000682 000
H6792122240 K000682 000
H6792122250 K000682 000
H6792122260 K000682 000
H6792122270 K000682 000
H6792134180 K000682 000
H6792134260 K000682 000
H6792122200 K000682 000
H6792122190 K000682 000
H6792122100 K000682 000
H6792122110 K000682 000
H6792122120 K000682 000
H6792122130 K000682 000
H6792122140 K000682 000
H6792122150 K000682 000
H6792122160 K000682 000
H6792122170 K000682 000
H6792122180 K000682 000
H6792134400 K000682 000
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.