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 |