EVOLUTION Revision CCK System
FDA 510(k) clearance K171389 · decided 2017-08-08
Clearance details
- K-number
- K171389
- Device name
- EVOLUTION Revision CCK System
- Applicant
- Microport Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-05-11
- Decision date
- 2017-08-08
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Arlington, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Microport Orthopedics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ceramic Transcend® Hip Articulation System (P030027/S005) | Microport Orthopedics, Inc. | 2018-02-16 |
| CERAMIC TRANSCEND HIP ARTICULATION (P030027/S009) | Microport Orthopedics, Inc. | 2016-09-01 |
| CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S008) | Microport Orthopedics, Inc. | 2015-12-30 |
| CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S007) | Microport Orthopedics, Inc. | 2014-01-03 |
| CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S006) | Microport Orthopedics, Inc. | 2013-06-20 |
| CONSERVE PLUS TOTAL RESURFACING SYSTEM (P030042/S004) | Microport Orthopedics, Inc. | 2011-08-08 |
| CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM (P030042/S002) | Microport Orthopedics, Inc. | 2010-07-16 |
| CONSERVE PLUS HIP RESURFACING SYSTEM NEW ENROLLMENT STUDY (NES) PROTOCOL (P030042/S003) | Microport Orthopedics, Inc. | 2010-06-21 |