Metal Cannulated Screw
FDA 510(k) K221090 · Double Medical Technology, Inc.
510(k) numberK221090
Submission
- Device name
- Metal Cannulated Screw
- Applicant
- Double Medical Technology, Inc.
Xiamen, CN - Received
- April 13, 2022
- Decision date
- January 10, 2023
- 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 |
|---|---|---|
| K252729 | Universal Spinal SystemNKB · Traditional | 11/18/2025SE |
| K242348 | Locking Screw,CoCrMoHWC · Abbreviated | 12/04/2024SE |
| K233078 | Posterior Cervical Spine SystemNKG · Traditional | 11/22/2023SE |
| K223753 | Cervical Plate SystemKWQ · Traditional | 03/14/2023SE |
| K221150 | Advanced Bone PlateHRS · Traditional | 01/25/2023SE |
| K221088 | Anatomic Bone PlateHRS · Traditional | 01/18/2023SE |
| K221221 | Advanced Intramedullary Nail SystemHSB · Traditional | 12/21/2022SE |
| K220921 | Metal Bone ScrewHWC · Traditional | 12/12/2022SE |
| K172830 | Double Medical Femoral Nail SystemHSB · Traditional | 08/24/2018SE |
| K172828 | Double Medical Cage SystemMAX · Traditional | 02/01/2018SE |
Questions and answers
When was Metal Cannulated Screw cleared by the FDA?
Metal Cannulated Screw (K221090) received a 510(k) decision of Substantially Equivalent on January 10, 2023, 272 days after the submission was received.
What is the product code of K221090?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.