The following data is part of a premarket notification filed by Dne, Llc with the FDA for D.n.e. External Fixation System.
| Device ID | K151580 |
| 510k Number | K151580 |
| Device Name: | D.N.E. External Fixation System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | DNE, LLC 2225 PARK PLACE Slatington, PA 18080 |
| Contact | Nicholas Riccione |
| Correspondent | Christine Scifert MEMPHIS REGULATORY CONSULTING, LLC 3416 ROXEE RUN COVE Bartlett, TN 38133 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-11 |
| Decision Date | 2016-02-16 |
| Summary: | summary |