SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER

Screw, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 2.7 Mm Cannulated Screw And Threaded Washer.

Pre-market Notification Details

Device IDK951304
510k NumberK951304
Device Name:SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
ClassificationScrew, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-22
Decision Date1995-06-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6794026140 K951304 000
H6794027200 K951304 000
H6794027190 K951304 000
H6794027180 K951304 000
H6794027170 K951304 000
H6794027160 K951304 000
H6794027150 K951304 000
H6794027140 K951304 000
H6794026400 K951304 000
H6794027210 K951304 000
H6794027220 K951304 000
H6794027300 K951304 000
H6794027290 K951304 000
H6794027280 K951304 000
H6794027270 K951304 000
H6794027260 K951304 000
H6794027250 K951304 000
H6794027240 K951304 000
H6794027230 K951304 000
H6794026380 K951304 000
H6794026360 K951304 000
H6794026220 K951304 000
H6794026210 K951304 000
H6794026200 K951304 000
H6794026190 K951304 000
H6794026180 K951304 000
H6794026170 K951304 000
H6794026160 K951304 000
H6794026150 K951304 000
H6794026230 K951304 000
H6794026240 K951304 000
H6794026340 K951304 000
H6794026320 K951304 000
H6794026300 K951304 000
H6794026290 K951304 000
H6794026280 K951304 000
H6794026270 K951304 000
H6794026260 K951304 000
H6794026250 K951304 000
H6794027320 K951304 000
H6794027340 K951304 000
H6792027200 K951304 000
H6792027190 K951304 000
H6792027180 K951304 000
H6792027170 K951304 000
H6792027160 K951304 000
H6792027150 K951304 000
H6792027140 K951304 000
H6792026400 K951304 000
H6792027220 K951304 000
H6792027240 K951304 000
H6792027400 K951304 000
H6792027380 K951304 000
H6792027360 K951304 000
H6792027340 K951304 000
H6792027320 K951304 000
H6792027300 K951304 000
H6792027280 K951304 000
H6792027260 K951304 000
H6792026380 K951304 000
H6792026360 K951304 000
H6792026170 K951304 000
H6792026160 K951304 000
H6792026150 K951304 000
H6792026140 K951304 000
H679419890 K951304 000
H6794027400 K951304 000
H6794027380 K951304 000
H6794027360 K951304 000
H6792026180 K951304 000
H6792026190 K951304 000
H6792026340 K951304 000
H6792026320 K951304 000
H6792026300 K951304 000
H6792026280 K951304 000
H6792026260 K951304 000
H6792026240 K951304 000
H6792026220 K951304 000
H6792026200 K951304 000
H679219890 K951304 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.