OsteoCentric Technologies Cannulated Fasteners and Nuts
FDA 510(k) K242691 · OsteoCentric Technologies
510(k) numberK242691
Submission
- Device name
- OsteoCentric Technologies Cannulated Fasteners and Nuts
- Applicant
- OsteoCentric Technologies
Logan, UT, US - Received
- September 9, 2024
- Decision date
- October 9, 2024
- 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 |
|---|---|---|
| K250520 | OsteoCentric Navigated Instruments SystemOLO · Traditional | 10/27/2025SE |
| K251913 | OsteoCentric® UnifiMI® TCS Plating SystemHRS · Special | 08/16/2025SE |
| K250494 | The OsteoCentric Bone Plate and Screw SystemHRS · Special | 03/18/2025SE |
| K230242 | OsteoCentric Dental Implant SystemDZE · Traditional | 10/05/2023SE |
| K230226 | Integrity-SI® Fusion SystemOUR · Special | 09/21/2023SE |
| K230595 | OsteoCentric ACL Fixation SystemHWC · Traditional | 06/29/2023SE |
| K230764 | OsteoCentric Integrated Hip Fastener SystemJDO · Special | 04/18/2023SE |
| K222512 | Integrity-SI Fusion SystemOUR · Special | 09/12/2022SE |
| K221332 | OsteoCentric Spine MIS Pedicle Fastener SystemNKB · Traditional | 07/28/2022SE |
| K211290 | Cannulated Fasteners and NutsHWC · Special | 08/03/2021SE |
Questions and answers
When was OsteoCentric Technologies Cannulated Fasteners and Nuts cleared by the FDA?
OsteoCentric Technologies Cannulated Fasteners and Nuts (K242691) received a 510(k) decision of Substantially Equivalent on October 9, 2024, 30 days after the submission was received.
What is the product code of K242691?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.