Omnitech Large, Trimed Compression Screw
FDA 510(k) K093676 · TriMed, Inc.
510(k) numberK093676
Submission
- Device name
- Omnitech Large, Trimed Compression Screw
- Applicant
- TriMed, Inc.
Valencia, CA, US - Received
- November 27, 2009
- Decision date
- March 17, 2010
- 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 |
|---|---|---|
| K262344 | Large Compression ScrewsHWC · Special | 08/12/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | 07/16/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | 05/14/2026SE |
| K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S)…HRS · Special | 01/15/2026SE |
| K252061 | Distal Xtremities SystemHRS · Traditional | 08/20/2025SE |
| K251134 | RipCordHTN · Traditional | 07/11/2025SE |
| K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)HRS · Special | 07/10/2025SE |
| K250929 | TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar…HRS · Traditional | 06/26/2025SE |
| K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…HRS · Traditional | 05/22/2025SE |
| K243943 | TriMed® Compression ScrewsHWC · Traditional | 04/10/2025SE |
Questions and answers
When was Omnitech Large, Trimed Compression Screw cleared by the FDA?
Omnitech Large, Trimed Compression Screw (K093676) received a 510(k) decision of Substantially Equivalent on March 17, 2010, 110 days after the submission was received.
What is the product code of K093676?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.