Stabilization Screw
FDA 510(k) K131920 · In2bones Sas
510(k) numberK131920
Submission
- Device name
- Stabilization Screw
- Applicant
- In2bones Sas
Potomac, MD, US - Received
- June 26, 2013
- Decision date
- May 1, 2014
- 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 |
|---|---|---|
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) SystemHSN · Traditional | 04/23/2024SE |
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) SystemHSN · Traditional | 04/06/2023SE |
| K211883 | QUANTUM® Patient Specific Instrumentation (PSI) SystemHSN · Traditional | 08/11/2021SE |
| K191380 | Quantum® Total Ankle ProsthesisHSN · Traditional | 01/29/2020SE |
| K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemHSB · Traditional | 03/15/2018SE |
| K173616 | DIP Arthrodesis SystemHTY · Traditional | 01/19/2018SE |
| K173121 | Ankle Fusion Plating SystemHRS · Traditional | 11/28/2017SE |
| K170688 | PITStop® implantHWC · Traditional | 11/28/2017SE |
| K170594 | I.B.S. osteosynthesis screwsHWC · Special | 05/10/2017SE |
| K160174 | I.B.S. 2.0 Osteosynthesis screwHWC · Traditional | 10/06/2016SE |
Questions and answers
When was Stabilization Screw cleared by the FDA?
Stabilization Screw (K131920) received a 510(k) decision of Substantially Equivalent on May 1, 2014, 309 days after the submission was received.
What is the product code of K131920?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.