The following data is part of a premarket notification filed by D.n.e., Llc with the FDA for Dne External Fixation System.
| Device ID | K113106 |
| 510k Number | K113106 |
| Device Name: | DNE EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | D.N.E., LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb D.N.E., LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-20 |
| Decision Date | 2012-01-04 |
| Summary: | summary |