Opus Magnum Anchor & Inserter
FDA 510(k) K012125 · Opus Medical, Inc.
510(k) numberK012125
Submission
- Device name
- Opus Magnum Anchor & Inserter
- Applicant
- Opus Medical, Inc.
San Juan Capistrano, CA, US - Received
- July 6, 2001
- Decision date
- September 17, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | Paragon 28, Inc. | 08/28/2026SE |
| K253325 | ZipToe Hammertoe Fusion SystemHTY · Traditional | Toetal Solutions | 12/29/2025SE |
| K252657 | Impact PEEK Union Nail SystemHTY · Special | Nvision Biomedical Technologies, Inc. | 09/19/2025SE |
| K250315 | Ronavis FX (FX-001)HTY · Traditional | AIRS, Inc. | 08/01/2025SE |
| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | OrthoPediatrics Corp. | 06/24/2025SE |
| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | Nvision Biomedical Technologies | 06/11/2025SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
| K231147 | Hammerdesis Interphalangeal Fusion SystemHTY · Traditional | Intelivation | 09/14/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
More from OSSIO , 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 |
| 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 |
Questions and answers
When was Opus Magnum Anchor & Inserter cleared by the FDA?
Opus Magnum Anchor & Inserter (K012125) received a 510(k) decision of Substantially Equivalent on September 17, 2001, 73 days after the submission was received.
What is the product code of K012125?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.