The following data is part of a premarket notification filed by Trilliant Surgical, Ltd with the FDA for Gridlock Ankle Plating System.
| Device ID | K160177 |
| 510k Number | K160177 |
| Device Name: | Gridlock Ankle Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Trilliant Surgical, LTD 6721 Portwest Dr Ste 160 Houston, TX 77024 |
| Contact | Jon Olson |
| Correspondent | J.d. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-04-22 |
| Summary: | summary |