SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 4.5 Mm Va-lcp Curved Condylar System.

Pre-market Notification Details

• Device ID: K083025
• 510k Number: K083025
• Device Name: SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM
• 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
• Subsequent Product Code: HWC
• Subsequent Product Code: JDP
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-10-10
• Decision Date: 2009-01-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H679021244120	K083025	000
H679021227130	K083025	000
H679021227100	K083025	000
H679021227090	K083025	000
H679021227080	K083025	000
H679021227070	K083025	000
H679021227060	K083025	000
H679022221900	K083025	000
H679022221850	K083025	000
H679022221800	K083025	000
H679021244060	K083025	000
H67902124406S0	K083025	000
H679021244070	K083025	000
H67902124411S0	K083025	000
H679021244110	K083025	000
H67902124410S0	K083025	000
H679021244100	K083025	000
H67902124409S0	K083025	000
H679021244090	K083025	000
H67902124408S0	K083025	000
H679021244080	K083025	000
H67902124407S0	K083025	000
H679022221750	K083025	000
H679022221700	K083025	000
H679022221320	K083025	000
H679022221300	K083025	000
H679022221280	K083025	000
H679022221260	K083025	000
H679022221240	K083025	000
H679022221220	K083025	000
H679022221200	K083025	000
H679022221180	K083025	000
H679022221160	K083025	000
H679022221340	K083025	000
H679022221360	K083025	000
H679022221380	K083025	000
H679022221650	K083025	000
H679022221600	K083025	000
H679022221550	K083025	000
H679022221500	K083025	000
H679022221480	K083025	000
H679022221460	K083025	000
H679022221440	K083025	000
H679022221420	K083025	000
H679022221400	K083025	000
H679022221140	K083025	000
H679022312900	K083025	000
H679022312400	K083025	000
H679022312380	K083025	000
H679022312360	K083025	000
H679022312340	K083025	000
H679022312320	K083025	000
H679022312300	K083025	000
H679022312280	K083025	000
H679022312260	K083025	000
H679022312240	K083025	000
H679022312420	K083025	000
H679022312440	K083025	000
H679022312460	K083025	000
H679022312850	K083025	000
H679022312800	K083025	000
H679022312750	K083025	000
H679022312700	K083025	000
H679022312650	K083025	000
H679022312600	K083025	000
H679022312550	K083025	000
H679022312500	K083025	000
H679022312480	K083025	000
H679022312220	K083025	000
H679022312200	K083025	000
H679021244170	K083025	000
H67902124416S0	K083025	000
H679021244160	K083025	000
H67902124415S0	K083025	000
H679021244150	K083025	000
H67902124414S0	K083025	000
H679021244140	K083025	000
H67902124413S0	K083025	000
H679021244130	K083025	000
H67902124417S0	K083025	000
H679021244180	K083025	000
H67902124418S0	K083025	000
H679022312180	K083025	000
H679022312160	K083025	000
H679022312140	K083025	000
H67902124423S0	K083025	000
H67902124422S0	K083025	000
H67902124421S0	K083025	000
H67902124420S0	K083025	000
H67902124419S0	K083025	000
H679021244190	K083025	000
H67902124412S0	K083025	000