MagnetOs Putty
FDA 510(k) clearance K181958 · decided 2018-12-06
Clearance details
- K-number
- K181958
- Device name
- MagnetOs Putty
- Applicant
- Kuros Biosciences B.V
- Decision
- Substantially Equivalent
- Date received
- 2018-07-23
- Decision date
- 2018-12-06
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Bilthoven, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.