UNI KNEE
FDA 510(k) clearance K022437 · decided 2002-08-23
Clearance details
- K-number
- K022437
- Device name
- UNI KNEE
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-25
- Decision date
- 2002-08-23
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- HRY
- Device class
- 2
- Regulation number
- 888.3530
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; kn recall (Z-0009-2008) | Encore Medical, Lp | 2007-10-10 |
| EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee recall (Z-0010-2008) | Encore Medical, Lp | 2007-10-10 |