The following data is part of a premarket notification filed by Virak Orthopedic Research, Llc with the FDA for Digifix External Fixation System.
| Device ID | K132731 |
| 510k Number | K132731 |
| Device Name: | DIGIFIX EXTERNAL FIXATION SYSTEM |
| Classification | Component, Traction, Invasive |
| Applicant | VIRAK ORTHOPEDIC RESEARCH, LLC 3416 ROXEE RUN COVE Bartlett, TN 38133 |
| Contact | Kimberly Strohkirch |
| Correspondent | Kimberly Strohkirch VIRAK ORTHOPEDIC RESEARCH, LLC 3416 ROXEE RUN COVE Bartlett, TN 38133 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-03 |
| Decision Date | 2014-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861988000327 | K132731 | 000 |
| 00861988000310 | K132731 | 000 |
| 00861988000303 | K132731 | 000 |