OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES
FDA 510(k) clearance K083240 · decided 2009-01-12
Clearance details
- K-number
- K083240
- Device name
- OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES
- Applicant
- Arthrocare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-03
- Decision date
- 2009-01-12
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor Intended for rotator cu recall (Z-0608-2012) | Innovatech Medical Resources L.P. | 2012-01-11 |
| OPUS Magnum 2 Plus Implant Product Number OM-9026 is one of two kits Intended for rotator recall (Z-0609-2012) | Innovatech Medical Resources L.P. | 2012-01-11 |
| OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with product number O recall (Z-0610-2012) | Innovatech Medical Resources L.P. | 2012-01-11 |