The following data is part of a premarket notification filed by Trilliant Surgical, Ltd with the FDA for Tiger Cannulated Screw System.
Device ID | K153338 |
510k Number | K153338 |
Device Name: | Tiger Cannulated Screw System |
Classification | Screw, Fixation, Bone |
Applicant | Trilliant Surgical, LTD 6721 Portwest Dr Ste 160 Houston, TX 77024 |
Contact | Jon Olson |
Correspondent | J.d. Webb The OrthoMedix Group 1001 Oakwood Blvd Round Rock, TX 78681 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-19 |
Decision Date | 2016-01-14 |
Summary: | summary |