The following data is part of a premarket notification filed by Hnm Total Recon, Llc with the FDA for Draco Locking Bone Screws; Draco Compression Screws; Draco Metafuse L Plates; Draco Metafuse Blp Plates; Draco Metafuse Mtp Plates, Takú Plates, Duotakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates.
| Device ID | K163486 |
| 510k Number | K163486 |
| Device Name: | DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | HNM Total Recon, LLC 20855 NE 16th Ave Suite C15 Miami, FL 33179 |
| Contact | Noah Roitman |
| Correspondent | Craig Pagan D2D Development, LLC 1135 W NASA Blvd. Melbourne, FL 32901 |
| Product Code | KTT |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HTY |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-12 |
| Decision Date | 2017-07-24 |