The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Kmedic Internal/external Fixation Devices.
| Device ID | K070561 |
| 510k Number | K070561 |
| Device Name: | KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES |
| Classification | Pin, Fixation, Smooth |
| Applicant | TELEFLEX MEDICAL 2345 WAUKEGAN ROAD SUITE 120 Bannockburn, IL 60015 |
| Contact | Lori Hays |
| Correspondent | Lori Hays TELEFLEX MEDICAL 2345 WAUKEGAN ROAD SUITE 120 Bannockburn, IL 60015 |
| Product Code | HTY |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-27 |
| Decision Date | 2007-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026704292356 | K070561 | 000 |
| 24026704278958 | K070561 | 000 |
| 04026704278947 | K070561 | 000 |
| 04026704278954 | K070561 | 000 |
| 04026704278978 | K070561 | 000 |
| 04026704292226 | K070561 | 000 |
| 04026704292233 | K070561 | 000 |
| 04026704292240 | K070561 | 000 |
| 04026704292257 | K070561 | 000 |
| 04026704292264 | K070561 | 000 |
| 04026704292295 | K070561 | 000 |
| 04026704292318 | K070561 | 000 |
| 04026704292325 | K070561 | 000 |
| 04026704292332 | K070561 | 000 |
| 04026704292349 | K070561 | 000 |
| 24026704278941 | K070561 | 000 |