DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM

Plate, Fixation, Bone

SYNTHES USA

The following data is part of a premarket notification filed by Synthes Usa with the FDA for Depuy Synthes Variable Angle Locking Hand System.

Pre-market Notification Details

• Device ID: K141527
• 510k Number: K141527
• Device Name: DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: SYNTHES USA 1301 GOSHEN PKWY West Chester, PA 19380
• Contact: Angela F Lassandro
• Correspondent: Nicholas Fountoulakis; 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: 2014-06-09
• Decision Date: 2015-03-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H67904130268S0	K141527	000
H679041302610	K141527	000
H679041302600	K141527	000
H67904130259S0	K141527	000
H679041302590	K141527	000
H67904130258S0	K141527	000
H679041302580	K141527	000
H67904130257S0	K141527	000
H679041302570	K141527	000
H67904130256S0	K141527	000
H679041302560	K141527	000
H67904130255S0	K141527	000
H67904130261S0	K141527	000
H679041302620	K141527	000
H67904130262S0	K141527	000
H679041302680	K141527	000
H67904130267S0	K141527	000
H679041302670	K141527	000
H67904130266S0	K141527	000
H679041302660	K141527	000
H67904130265S0	K141527	000
H679041302650	K141527	000
H67904130264S0	K141527	000
H679041302640	K141527	000
H67904130263S0	K141527	000
H679041302630	K141527	000
H679041302550	K141527	000
H67904130254S0	K141527	000
H679041302540	K141527	000
H679041302140	K141527	000
H679041302130	K141527	000
H679041302120	K141527	000
H679041302110	K141527	000
H679041302100	K141527	000
H679041302090	K141527	000
H679041302080	K141527	000
H679041302070	K141527	000
H679041302060	K141527	000
H679041302050	K141527	000
H679041302040	K141527	000
H679041302150	K141527	000
H679041302160	K141527	000
H679041302180	K141527	000
H67904130253S0	K141527	000
H679041302530	K141527	000
H67904130252S0	K141527	000
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H67904130251S0	K141527	000
H679041302510	K141527	000
H67904130250S0	K141527	000
H679041302500	K141527	000
H679041302240	K141527	000
H679041302220	K141527	000
H679041302200	K141527	000
H67904130260S0	K141527	000
H67902130268S0	K141527	000
H679021302610	K141527	000
H67902130260S0	K141527	000
H679021302600	K141527	000
H67902130259S0	K141527	000
H679021302590	K141527	000
H67902130258S0	K141527	000
H679021302580	K141527	000
H67902130257S0	K141527	000
H679021302570	K141527	000
H67902130256S0	K141527	000
H679021302560	K141527	000
H67902130261S0	K141527	000
H679021302620	K141527	000
H67902130262S0	K141527	000
H679021302680	K141527	000
H67902130267S0	K141527	000
H679021302670	K141527	000
H67902130266S0	K141527	000
H679021302660	K141527	000
H67902130265S0	K141527	000
H679021302650	K141527	000
H67902130264S0	K141527	000
H679021302640	K141527	000
H67902130263S0	K141527	000
H679021302630	K141527	000
H67902130255S0	K141527	000
H679021302550	K141527	000
H67902130254S0	K141527	000
H679021302150	K141527	000
H679021302140	K141527	000
H679021302130	K141527	000
H679021302120	K141527	000
H679021302110	K141527	000
H679021302100	K141527	000
H679021302090	K141527	000
H679021302080	K141527	000
H679021302070	K141527	000
H679021302060	K141527	000
H679021302050	K141527	000
H679021302160	K141527	000
H679021302180	K141527	000
H679021302200	K141527	000
H679021302540	K141527	000
H67902130253S0	K141527	000
H679021302530	K141527	000
H67902130252S0	K141527	000
H679021302520	K141527	000
H67902130251S0	K141527	000
H679021302510	K141527	000
H67902130250S0	K141527	000
H679021302500	K141527	000
H679021302240	K141527	000
H679021302220	K141527	000
H679021302040	K141527	000