IBS-B MIS Beveled Screw System
FDA 510(k) K231236 · In2bones USA, LLC
510(k) numberK231236
Submission
- Device name
- IBS-B MIS Beveled Screw System
- Applicant
- In2bones USA, LLC
Memphis, TN, US - Received
- April 28, 2023
- Decision date
- July 27, 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 |
|---|---|---|
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | 05/30/2026SE |
| K241387 | CoLink NeoFuse MIS Plating System (see attached parts list)HRS · Traditional | 08/13/2024SE |
| K233089 | NeoSpan® Compression Implant SystemHRS · Traditional | 05/24/2024SE |
| K213698 | CoLink PCR Plating SystemHRS · Traditional | 05/27/2022SE |
| K220260 | Hercules Syndesmosis Implant SystemHTN · Traditional | 03/31/2022SE |
| K212872 | Avenger Radial Head SystemKWI · Traditional | 12/17/2021SE |
| K213069 | CoLink NeoFuse Plating SystemHRS · Traditional | 12/13/2021SE |
| K212487 | CoLink Vallux Plating SystemHRS · Traditional | 11/18/2021SE |
| K203698 | CoLink Sfx Implant SystemHTY · Traditional | 05/04/2021SE |
| K210060 | CoLink Mfx Implant SystemHRS · Traditional | 03/12/2021SE |
Questions and answers
When was IBS-B MIS Beveled Screw System cleared by the FDA?
IBS-B MIS Beveled Screw System (K231236) received a 510(k) decision of Substantially Equivalent on July 27, 2023, 90 days after the submission was received.
What is the product code of K231236?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.