SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE
FDA 510(k) clearance K915818 · decided 1992-01-17
Clearance details
- K-number
- K915818
- Device name
- SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 1991-12-30
- Decision date
- 1992-01-17
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Paoli, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6H recall (Z-0236-2016) | Synthes (USA) Products LLC | 2015-11-06 |
| Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch T recall (Z-1174-2014) | Synthes, Inc. | 2014-03-11 |
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 |