Cordera Hip System
FDA 510(k) clearance K202484 · decided 2020-09-24
Clearance details
- K-number
- K202484
- Device name
- Cordera Hip System
- Applicant
- Conformis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-08-31
- Decision date
- 2020-09-24
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Billerica, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Conformis
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
| Record | Firm | Date |
|---|---|---|
| restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-0 recall (Z-1569-2025) | Conformis Inc. | 2025-04-15 |
| CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO recall (Z-2405-2023) | Conformis, Inc. | 2023-08-16 |