Opus Minimagnum Anchor with Inserter
FDA 510(k) K042584 · Opus Medical, Inc.
510(k) numberK042584
Submission
- Device name
- Opus Minimagnum Anchor with Inserter
- Applicant
- Opus Medical, Inc.
San Juan Capistrano, CA, US - Received
- September 22, 2004
- Decision date
- December 14, 2004
- 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 |
|---|---|---|
| K042914 | Opus Magnum Knotless Anchor with Inserter HandleMBI · Special | 11/12/2004SE |
| K042031 | Opus Speedstitch Suture DeviceGAT · Traditional | 10/19/2004SE |
| K041440 | Opus Magnum Anchor with InserterMBI · Special | 06/25/2004SE |
| K033317 | Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System…OCW · Traditional | 12/30/2003SE |
| K030170 | Reusable Smartstitch Suture Device, Models OM-8007, OM-8500OCW · Traditional | 07/28/2003SE |
| K031083 | Opus Magnum Implant System, Model OM-1500HTY · Traditional | 06/12/2003SE |
| K030235 | F1 Diode Laser SystemGEX · Traditional | 04/23/2003SE |
| K023843 | Smartstitch M-Connector, Model OM-8005; Smartstitch Actuation Handle, Model OM-8500; and…OCW · Traditional | 02/14/2003SE |
| K022229 | Smartstitch Suture Device, Model OM-8500OCW · Traditional | 09/06/2002SE |
| K020172 | Opus Magnum Anchor & Instrument SetMBI · Abbreviated | 07/22/2002SE |
Questions and answers
When was Opus Minimagnum Anchor with Inserter cleared by the FDA?
Opus Minimagnum Anchor with Inserter (K042584) received a 510(k) decision of Substantially Equivalent on December 14, 2004, 83 days after the submission was received.
What is the product code of K042584?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.