Bencox M Stem Lateralized & Bencox Mirabo Cup System
FDA 510(k) clearance K162127 · decided 2016-12-05
Clearance details
- K-number
- K162127
- Device name
- Bencox M Stem Lateralized & Bencox Mirabo Cup System
- Applicant
- Corentec Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-08-01
- Decision date
- 2016-12-05
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Cheonan, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343 recall (Z-1454-2017) | CORENTEC CO., LTD | 2017-03-13 |