Libertas E-XLPE Modular Liner
FDA 510(k) clearance K192989 · decided 2020-10-29
Clearance details
- K-number
- K192989
- Device name
- Libertas E-XLPE Modular Liner
- Applicant
- Maxx Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-10-25
- Decision date
- 2020-10-29
- Days to decision
- 370 days
- Clearance type
- Traditional
- Product code
- OQI
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Norristown, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EPORE® XO cup system (K252451) | Implantcast GmbH | 2026-04-24 |
| E-XPE Acetabular Components and U-Motion II Acetabular Cup (K172833) | United Orthopedic Corporation | 2018-06-12 |
| Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners (K173583) | Exactech, Inc. | 2018-03-12 |
| CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS (K111481) | Corin USA | 2012-02-06 |
Recalls involving this device
No recalls on record reference this clearance.