The following data is part of a premarket notification filed by Teleflex Medical Group with the FDA for Kmedic External Fixation Devices.
| Device ID | K030336 |
| 510k Number | K030336 |
| Device Name: | KMEDIC EXTERNAL FIXATION DEVICES |
| Classification | Pin, Fixation, Threaded |
| Applicant | TELEFLEX MEDICAL GROUP 50 PLANTATION DR. Jaffrey, NH 03452 |
| Contact | Rick Lykins |
| Correspondent | Rick Lykins TELEFLEX MEDICAL GROUP 50 PLANTATION DR. Jaffrey, NH 03452 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-31 |
| Decision Date | 2003-03-06 |
| Summary: | summary |