The following data is part of a premarket notification filed by Instratek, Inc. with the FDA for Jones-fx Fracture System.
| Device ID | K131620 |
| 510k Number | K131620 |
| Device Name: | JONES-FX FRACTURE SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | INSTRATEK, INC. 15200 Middlebrook Dr Ste G Houston, TX 77058 |
| Contact | Jeff Seavey |
| Correspondent | Jeff Seavey INSTRATEK, INC. 15200 Middlebrook Dr Ste G Houston, TX 77058 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-03 |
| Decision Date | 2013-07-25 |
| Summary: | summary |