The following data is part of a premarket notification filed by Synthes Usa with the FDA for Depuy Synthes Variable Angle Locking Hand System.
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 |
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 |
H679041302520 | K141527 | 000 |
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 |