Healix Compression Screw System
FDA 510(k) K182949 · Nvision Biomedical Technologies, LLC
510(k) numberK182949
Submission
- Device name
- Healix Compression Screw System
- Applicant
- Nvision Biomedical Technologies, LLC
San Antonio, TX, US - Received
- October 23, 2018
- Decision date
- December 4, 2018
- 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.
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| K252657 | Impact PEEK Union Nail SystemHTY · Special | 09/19/2025SE |
| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | 06/11/2025SE |
| K250613 | SnapHammer Hammertoe Correction SystemHWC · Special | 04/02/2025SE |
| K242896 | Caliber Intramedullary Fixation SystemHWC · Traditional | 02/05/2025SE |
| K243231 | Trigon PEEK HA WedgesPLF · Special | 11/08/2024SE |
| K240250 | 3D Printed PEEK Interbody SystemMAX · Traditional | 09/17/2024SE |
| K231453 | SnapHammer Hammertoe Correction SystemHWC · Traditional | 02/16/2024SE |
Questions and answers
When was Healix Compression Screw System cleared by the FDA?
Healix Compression Screw System (K182949) received a 510(k) decision of Substantially Equivalent on December 4, 2018, 42 days after the submission was received.
What is the product code of K182949?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.