SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP)

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 3.5 Mm And 4.55 Mm Curved Narrow And Broad Locking Compression Plates (lcp).

Pre-market Notification Details

• Device ID: K092609
• 510k Number: K092609
• Device Name: SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP)
• Classification: Plate, Fixation, Bone
• Applicant: SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380
• Contact: Sheri L Musgnung
• Correspondent: Sheri L Musgnung; SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-08-25
• Decision Date: 2009-11-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H67904161210S0	K092609	000
H67904161282S0	K092609	000
H67904161284S0	K092609	000
H67904161286S0	K092609	000
H67904161288S0	K092609	000
H67904161290S0	K092609	000
H679021612100	K092609	000
H67902161210S0	K092609	000
H679021612120	K092609	000
H67902161212S0	K092609	000
H679021612140	K092609	000
H67902161214S0	K092609	000
H679021612160	K092609	000
H67902161216S0	K092609	000
H679021612180	K092609	000
H67902161218S0	K092609	000
H679021612200	K092609	000
H67904161280S0	K092609	000
H67904161278S0	K092609	000
H67904161276S0	K092609	000
H67904161212S0	K092609	000
H67904161214S0	K092609	000
H67904161216S0	K092609	000
H67904161218S0	K092609	000
H67904161220S0	K092609	000
H67904161222S0	K092609	000
H67904161240S0	K092609	000
H67904161242S0	K092609	000
H67904161244S0	K092609	000
H67904161246S0	K092609	000
H67904161248S0	K092609	000
H67904161250S0	K092609	000
H67904161252S0	K092609	000
H67904161270S0	K092609	000
H67904161272S0	K092609	000
H67904161274S0	K092609	000
H67902161220S0	K092609	000
H679021612220	K092609	000
H67902161222S0	K092609	000
H67902161274S0	K092609	000
H679021612760	K092609	000
H67902161276S0	K092609	000
H679021612780	K092609	000
H67902161278S0	K092609	000
H679021612800	K092609	000
H67902161280S0	K092609	000
H679021612820	K092609	000
H67902161282S0	K092609	000
H679021612840	K092609	000
H67902161284S0	K092609	000
H679021612860	K092609	000
H67902161286S0	K092609	000
H679021612880	K092609	000
H67902161288S0	K092609	000
H679021612900	K092609	000
H679021612740	K092609	000
H67902161272S0	K092609	000
H679021612720	K092609	000
H679021612400	K092609	000
H67902161240S0	K092609	000
H679021612420	K092609	000
H67902161242S0	K092609	000
H679021612440	K092609	000
H67902161244S0	K092609	000
H679021612460	K092609	000
H67902161246S0	K092609	000
H679021612480	K092609	000
H67902161248S0	K092609	000
H679021612500	K092609	000
H67902161250S0	K092609	000
H679021612520	K092609	000
H67902161252S0	K092609	000
H679021612700	K092609	000
H67902161270S0	K092609	000
H67902161290S0	K092609	000