Auxein Nailing System
FDA 510(k) K210792 · Auxein Medical Private Limited
510(k) numberK210792
Submission
- Device name
- Auxein Nailing System
- Applicant
- Auxein Medical Private Limited
Sonipat, IN - Received
- March 15, 2021
- Decision date
- August 25, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K221787 | Auxein's DHS/DCS Plate SystemKTT · Traditional | 11/30/2023SE |
| K213059 | Tibia and Fibula SystemHRS · Traditional | 01/27/2023SE |
| K213110 | AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorMBI · Traditional | 12/16/2022SE |
| K213018 | Auxilock GFS Mini, GFS II Large, and GFS UltimateMBI · Traditional | 11/18/2022SE |
| K213108 | Humerus & Ulna SystemHRS · Traditional | 11/04/2022SE |
| K213014 | Varixis Elbow SystemHRS · Traditional | 10/03/2022SE |
| K213109 | Auxilock Draw Tight Suture-Based AnchorMBI · Traditional | 08/22/2022SE |
| K213104 | Auxilock Titanium Screw-In Suture AnchorMBI · Traditional | 07/29/2022SE |
| K211324 | 2.4mm Distal Radius SystemHRS · Traditional | 03/14/2022SE |
| K203029 | Auxilock Titanium Interference ScrewHWC · Traditional | 08/20/2021SE |
Questions and answers
When was Auxein Nailing System cleared by the FDA?
Auxein Nailing System (K210792) received a 510(k) decision of Substantially Equivalent on August 25, 2021, 163 days after the submission was received.
What is the product code of K210792?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.