PROLIXUS TOTAL KNEE SYSTEM
FDA 510(k) clearance K170534 · decided 2017-11-09
Clearance details
- K-number
- K170534
- Device name
- PROLIXUS TOTAL KNEE SYSTEM
- Applicant
- Otis Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-02-23
- Decision date
- 2017-11-09
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Siheung-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.