PROMOS MODULAR SHOULDER SYSTEM
FDA 510(k) clearance K063578 · decided 2007-03-02
Clearance details
- K-number
- K063578
- Device name
- PROMOS MODULAR SHOULDER SYSTEM
- Applicant
- Plus Orthopedics AG
- Decision
- Substantially Equivalent
- Date received
- 2006-11-30
- Decision date
- 2007-03-02
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- HSD
- Device class
- 2
- Regulation number
- 888.3690
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Norfolk, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PROMOS Inclination set, SIZE 20mm, REF 42 180, S&N 75006722, QTY: (1), STERILE R, Smith & recall (Z-1239-2010) | Smith & Nephew Inc | 2010-04-07 |
| PROMOS Inclination set, SIZE 22mm, REF 42 182, S&N 75006723, QTY: (1), STERILE R, Smith & recall (Z-1240-2010) | Smith & Nephew Inc | 2010-04-07 |
| PROMOS Inclination set, SIZE 24mm, REF 42 184, S&N 75006724, QTY: (1), STERILE R, Smith & recall (Z-1241-2010) | Smith & Nephew Inc | 2010-04-07 |
| PROMOS Inclination set, SIZE 26mm, REF 42 186, S&N 75006725, QTY: (1), STERILE R, Smith & recall (Z-1242-2010) | Smith & Nephew Inc | 2010-04-07 |