SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
FDA 510(k) clearance K082650 · decided 2008-11-18
Clearance details
- K-number
- K082650
- Device name
- SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 2008-09-12
- Decision date
- 2008-11-18
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- KTT
- Device class
- 2
- Regulation number
- 888.3030
- 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 Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S recall (Z-2451-2015) | Synthes (USA) Products LLC | 2015-08-24 |
| Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance c recall (Z-1833-2014) | Synthes, Inc. | 2014-06-19 |
| Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, recall (Z-1816-2013) | Synthes USA HQ, Inc. | 2013-07-29 |
| Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: recall (Z-0941-2013) | Synthes USA HQ, Inc. | 2013-03-11 |
| Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use recall (Z-0277-2013) | Synthes USA HQ, Inc. | 2012-11-13 |
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 |