SYNTHES MODULAR FOOT SYSTEM

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Modular Foot System.

Pre-market Notification Details

• Device ID: K001941
• 510k Number: K001941
• Device Name: SYNTHES MODULAR FOOT SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222
• Contact: Angela J Silvestri
• Correspondent: Angela J Silvestri; SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-06-26
• Decision Date: 2000-09-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H6792016360	K001941	000
H6792016520	K001941	000
H6792016540	K001941	000
H6792016560	K001941	000
H6792016580	K001941	000
H6792016600	K001941	000
H6792016620	K001941	000
H6792016640	K001941	000
H6792016660	K001941	000
H6792016680	K001941	000
H6792016500	K001941	000
H6792016480	K001941	000
H6792016370	K001941	000
H6792016380	K001941	000
H6792016390	K001941	000
H6792016400	K001941	000
H6792016410	K001941	000
H6792016420	K001941	000
H6792016430	K001941	000
H6792016440	K001941	000
H6792016460	K001941	000
H6792016700	K001941	000
H6792018400	K001941	000
H6792019800	K001941	000
H6792499260	K001941	000
H6792499280	K001941	000
H980201806980	K001941	000
H980201808980	K001941	000
H980201810980	K001941	000
H980201812980	K001941	000
H980201814980	K001941	000
H6793921770	K001941	000
H6793921780	K001941	000
H6792499240	K001941	000
H6792499210	K001941	000
H6792432340	K001941	000
H6792435840	K001941	000
H6792435850	K001941	000
H6792435860	K001941	000
H6792435870	K001941	000
H6792435880	K001941	000
H6792499160	K001941	000
H6792499170	K001941	000
H6792499190	K001941	000
H6793921790	K001941	000