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 |