Opus Magnum Anchor with Inserter
FDA 510(k) K041440 · Opus Medical, Inc.
510(k) numberK041440
Submission
- Device name
- Opus Magnum Anchor with Inserter
- Applicant
- Opus Medical, Inc.
San Juan Capistrano, CA, US - Received
- June 1, 2004
- Decision date
- June 25, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262809 | ArthroTAK Tendon Anchor KitMBI · Special | ArthroTAK, LLC | 09/02/2026SE |
| K253065 | Aevumed SUPERCYNCH Button SystemMBI · Traditional | Aevumed, Inc. | 09/02/2026SE |
| K262677 | Iconix Knotless TMBI · Special | Riverpoint Medical | 08/27/2026SE |
| K262047 | Grappler Suture Anchor SystemMBI · Special | Paragon 28, Inc. | 08/03/2026SE |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair…MBI · Special | Stryker Endoscopy | 07/30/2026SE |
| K261770 | Suture Button Repair SystemMBI · Traditional | Skeletal Dynamics, Inc. | 07/29/2026SE |
| K261632 | Thunderbolt SystemMBI · Special | Responsive Arthroscopy, Inc. | 07/20/2026SE |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special | Smith & Nephew, Inc. | 07/09/2026SE |
| K260018 | Arthrex FiberButtonMBI · Traditional | Arthrex, Inc. | 06/26/2026SE |
| K253130 | Dione PEEK Screw SystemMBI · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/27/2026SE |
More from ZheJiang Decans Medical Devices Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K042584 | Opus Minimagnum Anchor with InserterHWC · Traditional | 12/14/2004SE |
| K042914 | Opus Magnum Knotless Anchor with Inserter HandleMBI · Special | 11/12/2004SE |
| K042031 | Opus Speedstitch Suture DeviceGAT · Traditional | 10/19/2004SE |
| 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 Magnum Anchor with Inserter cleared by the FDA?
Opus Magnum Anchor with Inserter (K041440) received a 510(k) decision of Substantially Equivalent on June 25, 2004, 24 days after the submission was received.
What is the product code of K041440?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.