Cortical Bone Screw
FDA 510(k) K931790 · Onyx Medical Corp.
510(k) numberK931790
Submission
- Device name
- Cortical Bone Screw
- Applicant
- Onyx Medical Corp.
Memphis, TN, US - Received
- April 12, 1993
- Decision date
- April 25, 1994
- 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 |
|---|---|---|
| K041679 | Cold Light; Cold Light MD; Gossamer DermlightILY · Abbreviated | 12/16/2004SE |
| K942022 | Face-It ShieldLYU · Traditional | 07/08/1994SE |
| K931690 | Spoon PlateHRS · Traditional | 06/07/1994SN |
| K934614 | Mini Fragment PlateHRS · Traditional | 05/04/1994SN |
| K931692 | T-PlateHRS · Traditional | 05/04/1994SN |
| K931684 | Epiphysis PlateHRS · Traditional | 05/04/1994SN |
| K931680 | Cannulated Cancellous ScrewHWC · Traditional | 05/04/1994SN |
| K934616 | Cancellous Bone ScrewHWC · Traditional | 04/25/1994SN |
| K934615 | Cancellous Bone ScrewHWC · Traditional | 04/25/1994SN |
| K931694 | 1/4 Tubular PlateHRS · Traditional | 04/25/1994SN |
Questions and answers
When was Cortical Bone Screw cleared by the FDA?
Cortical Bone Screw (K931790) received a 510(k) decision of Substantially Equivalent for Some Indications on April 25, 1994, 378 days after the submission was received.
What is the product code of K931790?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.