Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System
FDA 510(k) clearance K150544 · decided 2015-05-29
Clearance details
- K-number
- K150544
- Device name
- Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System
- Applicant
- Aesculap Implant Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-03-03
- Decision date
- 2015-05-29
- Days to decision
- 87 days
- Clearance type
- Special
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.