Tiger Cannulated Screw System
FDA 510(k) K153338 · Trilliant Surgical, Ltd.
510(k) numberK153338
Submission
- Device name
- Tiger Cannulated Screw System
- Applicant
- Trilliant Surgical, Ltd.
Houston, TX, US - Received
- November 19, 2015
- Decision date
- January 14, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K212378 | Arsenal Ankle Plating SystemHRS · Traditional | 02/23/2022SE |
| K191009 | Arsenal Plating SystemHRS · Traditional | 08/12/2019SE |
| K181898 | Two-Step Implant SystemHWC · Traditional | 10/26/2018SE |
| K172405 | Sniper Staple System, Non-SterileJDR · Traditional | 12/11/2017SE |
| K172178 | Minimally Invasive Bunion Plating SystemHRS · Traditional | 11/16/2017SE |
| K162354 | Sniper Staple SystemJDR · Traditional | 04/20/2017SE |
| K160177 | Gridlock Ankle Plating SystemHRS · Traditional | 04/22/2016SE |
| K130964 | Gridlock Plating SystemHRS · Special | 05/08/2013SE |
| K123525 | Gridlock Plating SystemHRS · Special | 02/15/2013SE |
| K122959 | Hammer Toe ImplantHWC · Traditional | 11/07/2012SE |
Questions and answers
When was Tiger Cannulated Screw System cleared by the FDA?
Tiger Cannulated Screw System (K153338) received a 510(k) decision of Substantially Equivalent on January 14, 2016, 56 days after the submission was received.
What is the product code of K153338?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.