Omnia Medical Trauma Screws
FDA 510(k) K192096 · Omnia Medical, LLC
510(k) numberK192096
Submission
- Device name
- Omnia Medical Trauma Screws
- Applicant
- Omnia Medical, LLC
Morgantown,, WV, US - Received
- August 5, 2019
- Decision date
- February 27, 2020
- 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 |
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| K242431 | Omnia Medical PsiF DNA SystemOUR · Traditional | 06/06/2025SE |
| K240623 | Omnia Medical TiBrid-SA SystemOVD · Traditional | 04/24/2024SE |
| K230424 | Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral…KWQ · Traditional | 04/12/2023SE |
| K223321 | Omnia Medical Coupler-C Anterior Cervical PlateKWQ · Traditional | 03/13/2023SE |
| K212612 | Omnia Medical TiBrid-SCOVE · Traditional | 11/15/2022SE |
| K203207 | Omnia Medical TiBrid-SAOVD · Traditional | 12/23/2020SE |
| K190363 | Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical…MAX · Traditional | 02/21/2020SE |
| K191778 | Omnia Medical VBRPLR · Special | 08/28/2019SE |
| K183659 | Omnia Medical Rotary PLIF SystemMAX · Traditional | 02/06/2019SE |
| K172323 | Omnia Medical VBRMQP · Traditional | 10/26/2017SE |
Questions and answers
When was Omnia Medical Trauma Screws cleared by the FDA?
Omnia Medical Trauma Screws (K192096) received a 510(k) decision of Substantially Equivalent on February 27, 2020, 206 days after the submission was received.
What is the product code of K192096?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.