Dyonics Fixation Screws
FDA 510(k) K945182 · Smith & Nephew Dyonics, Inc.
510(k) numberK945182
Submission
- Device name
- Dyonics Fixation Screws
- Applicant
- Smith & Nephew Dyonics, Inc.
Andover, MA, US - Received
- October 24, 1994
- Decision date
- January 24, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K955914 | Limited Reuse Arthroscopic BladesHRX · Traditional | 02/08/1996SE |
| K954627 | Ectra II Ligament Release SystemHRX · Traditional | 12/18/1995SN |
| K954989 | Dyonics Disposable Endoscopic Surgery BladesERL · Traditional | 11/27/1995SE |
| K953695 | Dyonics Disposable Arthroscopic BladesHRX · Traditional | 09/15/1995SE |
| K953387 | Ectra Ligament Release SystemHRX · Traditional | 08/09/1995SE |
| K936071 | Smith & Nephew Dyonics Inc. Electronic EndoscopeHET · Traditional | 08/19/1994SE |
| K934299 | Dyonics Disposable Arthroscopic Surgery Blades ModificationHRX · Traditional | 02/14/1994SE |
| K920267 | Dyonics Arthroscopic KitLRO · Traditional | 03/23/1993SEKD |
| K922176 | Intelijet Suction SupplyBTA · Traditional | 11/18/1992SE |
| K914963 | Smith & Nephew Dyonics TMJ Arthroscopy Inflow SetHRX · Traditional | 06/04/1992SE |
Questions and answers
When was Dyonics Fixation Screws cleared by the FDA?
Dyonics Fixation Screws (K945182) received a 510(k) decision of Substantially Equivalent for Some Indications on January 24, 1995, 92 days after the submission was received.
What is the product code of K945182?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.