The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Intertan Chs Locking Plate System Prox Fem Plates/screw.
| Device ID | K080434 |
| 510k Number | K080434 |
| Device Name: | INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW |
| Classification | Device, Fixation, Proximal Femoral, Implant |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Elizabeth Miller |
| Correspondent | Elizabeth Miller SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JDO |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-19 |
| Decision Date | 2008-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556129555 | K080434 | 000 |
| 03596010615053 | K080434 | 000 |
| 03596010615046 | K080434 | 000 |
| 03596010615039 | K080434 | 000 |
| 03596010615022 | K080434 | 000 |
| 03596010615015 | K080434 | 000 |
| 03596010615008 | K080434 | 000 |
| 03596010614995 | K080434 | 000 |
| 03596010614988 | K080434 | 000 |
| 03596010614971 | K080434 | 000 |
| 03596010614964 | K080434 | 000 |
| 03596010614957 | K080434 | 000 |
| 03596010614940 | K080434 | 000 |
| 03596010615060 | K080434 | 000 |
| 03596010615077 | K080434 | 000 |
| 03596010615084 | K080434 | 000 |
| 00885556129548 | K080434 | 000 |
| 00885556129531 | K080434 | 000 |
| 03596010615183 | K080434 | 000 |
| 03596010615176 | K080434 | 000 |
| 03596010615169 | K080434 | 000 |
| 03596010615152 | K080434 | 000 |
| 03596010615145 | K080434 | 000 |
| 03596010615138 | K080434 | 000 |
| 03596010615121 | K080434 | 000 |
| 03596010615114 | K080434 | 000 |
| 03596010615107 | K080434 | 000 |
| 03596010615091 | K080434 | 000 |
| 03596010614926 | K080434 | 000 |