SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
FDA 510(k) clearance K103002 · decided 2011-03-02
Clearance details
- K-number
- K103002
- Device name
- SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 2010-10-08
- Decision date
- 2011-03-02
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufac recall (Z-2059-2012) | Synthes USA HQ, Inc. | 2012-07-23 |
| 4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufac recall (Z-2060-2012) | Synthes USA HQ, Inc. | 2012-07-23 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NORIAN SRS BONE CEMENT (P970010/S004) | Synthes (Usa) | 2000-08-31 |
| NORIAN SRS CEMENT (P970010/S002) | Synthes (Usa) | 2000-04-28 |
| NORIAN SRS CEMENT (P970010/S001) | Synthes (Usa) | 1999-07-16 |
| NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010) | Synthes (Usa) | 1998-12-23 |