SYNTHES STERNAL ZIPFIX SYSTEM
FDA 510(k) clearance K110789 · decided 2011-07-28
Clearance details
- K-number
- K110789
- Device name
- SYNTHES STERNAL ZIPFIX SYSTEM
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 2011-03-22
- Decision date
- 2011-07-28
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- JDQ
- Device class
- 2
- Regulation number
- 888.3010
- 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 |
|---|---|---|
| Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or recall (Z-0276-2016) | Synthes (USA) Products LLC | 2015-11-14 |
| Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or recall (Z-2475-2015) | Synthes (USA) Products LLC | 2015-08-27 |
| Synthes Application Instrument Sternal Zip Flex System intended for use in primary or seco recall (Z-0114-2014) | Synthes USA HQ, Inc. | 2013-10-30 |
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 |