Nexis osteosynthesis snap-off screws
FDA 510(k) K143146 · Novastep
510(k) numberK143146
Submission
- Device name
- Nexis osteosynthesis snap-off screws
- Applicant
- Novastep
Saint Gregoire, FR - Received
- November 3, 2014
- Decision date
- February 6, 2015
- 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 |
|---|---|---|
| K260274 | Airlock® Ankle Plating SystemHRS · Abbreviated | 03/25/2026SE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional | 12/04/2023SE |
| K223468 | Nexis® compressive screwsHWC · Abbreviated | 08/30/2023SE |
| K192356 | Airlock Centrolock Osteosynthesis Implant SystemHRS · Traditional | 12/14/2019SE |
| K151277 | Airlock® osteosynthesis plate systemHRS · Traditional | 08/13/2015SE |
| K143523 | Airlock osteosynthesis plate systemHRS · Traditional | 04/06/2015SE |
| K143049 | LYNC intramedullary implantHTY · Traditional | 02/19/2015SE |
| K143229 | Nexis osteosynthesis compressive screwsHWC · Traditional | 02/06/2015SE |
Questions and answers
When was Nexis osteosynthesis snap-off screws cleared by the FDA?
Nexis osteosynthesis snap-off screws (K143146) received a 510(k) decision of Substantially Equivalent on February 6, 2015, 95 days after the submission was received.
What is the product code of K143146?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.