The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Synthes 2.7mm And 3.5mm Variable Angle Lcp Midfoot/hindfoot System.
| Device ID | K131186 |
| 510k Number | K131186 |
| Device Name: | SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Rebecca G Reiter |
| Correspondent | Rebecca G Reiter SYNTHES (USA) PRODUCTS LLC 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 | 2013-04-25 |
| Decision Date | 2013-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679042114000 | K131186 | 000 |
| H679042114090 | K131186 | 000 |
| H67904211409S0 | K131186 | 000 |
| H679042114100 | K131186 | 000 |
| H67904211410S0 | K131186 | 000 |
| H679042114110 | K131186 | 000 |
| H67904211411S0 | K131186 | 000 |
| H679042114120 | K131186 | 000 |
| H67904211412S0 | K131186 | 000 |
| H679042114130 | K131186 | 000 |
| H67904211413S0 | K131186 | 000 |
| H679022114000 | K131186 | 000 |
| H67902211400S0 | K131186 | 000 |
| H679022114010 | K131186 | 000 |
| H67902211401S0 | K131186 | 000 |
| H679022114020 | K131186 | 000 |
| H67904211408S0 | K131186 | 000 |
| H679042114080 | K131186 | 000 |
| H67904211400S0 | K131186 | 000 |
| H679042114010 | K131186 | 000 |
| H67904211401S0 | K131186 | 000 |
| H679042114020 | K131186 | 000 |
| H67904211402S0 | K131186 | 000 |
| H679042114030 | K131186 | 000 |
| H67904211403S0 | K131186 | 000 |
| H679042114040 | K131186 | 000 |
| H67904211404S0 | K131186 | 000 |
| H679042114050 | K131186 | 000 |
| H67904211405S0 | K131186 | 000 |
| H679042114060 | K131186 | 000 |
| H67904211406S0 | K131186 | 000 |
| H679042114070 | K131186 | 000 |
| H67904211407S0 | K131186 | 000 |
| H67902211402S0 | K131186 | 000 |
| H679022114030 | K131186 | 000 |
| H679022114120 | K131186 | 000 |
| H67902211412S0 | K131186 | 000 |
| H679022114130 | K131186 | 000 |
| H67902211413S0 | K131186 | 000 |
| H679022114160 | K131186 | 000 |
| H67902211416S0 | K131186 | 000 |
| H679022114170 | K131186 | 000 |
| H67902211417S0 | K131186 | 000 |
| H679022114180 | K131186 | 000 |
| H67902211418S0 | K131186 | 000 |
| H679022114190 | K131186 | 000 |
| H67902211419S0 | K131186 | 000 |
| H679022114200 | K131186 | 000 |
| H67902211420S0 | K131186 | 000 |
| H679022114210 | K131186 | 000 |
| H67902211411S0 | K131186 | 000 |
| H679022114110 | K131186 | 000 |
| H67902211403S0 | K131186 | 000 |
| H679022114040 | K131186 | 000 |
| H67902211404S0 | K131186 | 000 |
| H679022114050 | K131186 | 000 |
| H67902211405S0 | K131186 | 000 |
| H679022114060 | K131186 | 000 |
| H67902211406S0 | K131186 | 000 |
| H679022114070 | K131186 | 000 |
| H67902211407S0 | K131186 | 000 |
| H679022114080 | K131186 | 000 |
| H67902211408S0 | K131186 | 000 |
| H679022114090 | K131186 | 000 |
| H67902211409S0 | K131186 | 000 |
| H679022114100 | K131186 | 000 |
| H67902211410S0 | K131186 | 000 |
| H67902211421S0 | K131186 | 000 |