ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38
FDA 510(k) clearance K080402 · decided 2008-03-28
Clearance details
- K-number
- K080402
- Device name
- ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2008-02-14
- Decision date
- 2008-03-28
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- KWS
- Device class
- 2
- Regulation number
- 888.3660
- 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 |
|---|---|---|
| Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical recall (Z-0798-2011) | Encore Medical, Lp | 2010-12-22 |
| Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical recall (Z-0799-2011) | Encore Medical, Lp | 2010-12-22 |
| Turon Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical recall (Z-0800-2011) | Encore Medical, Lp | 2010-12-22 |
| Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, D recall (Z-0801-2011) | Encore Medical, Lp | 2010-12-22 |