The following data is part of a premarket notification filed by Virak Orthopedics, Llc with the FDA for Digifix Sterile Kit.
| Device ID | K192465 |
| 510k Number | K192465 |
| Device Name: | DigiFix Sterile Kit |
| Classification | Component, Traction, Invasive |
| Applicant | Virak Orthopedics, LLC 620 Essex St Harrison, NJ 07029 |
| Contact | Virak Tan |
| Correspondent | Christine Scifert MRC-X, LLC 6075 Poplar Ave Suite 500 Memphis, TN 38119 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-09 |
| Decision Date | 2019-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861988000334 | K192465 | 000 |