NEOVIEW Plating System
FDA 510(k) clearance K160995 · decided 2016-06-10
Clearance details
- K-number
- K160995
- Device name
- NEOVIEW Plating System
- Applicant
- In2bones Sas
- Decision
- Substantially Equivalent
- Date received
- 2016-04-08
- Decision date
- 2016-06-10
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Ecully, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, recall (Z-0952-2017) | In2Bones, SAS | 2017-01-06 |
| NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecull recall (Z-0953-2017) | In2Bones, SAS | 2017-01-06 |
| NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW Plating System is intended for recall (Z-0954-2017) | In2Bones, SAS | 2017-01-06 |