SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
FDA 510(k) clearance K011857 · decided 2001-09-12
Clearance details
- K-number
- K011857
- Device name
- SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 2001-06-14
- Decision date
- 2001-09-12
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- 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 |
|---|---|---|
| Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile recall (Z-0375-2016) | Synthes (USA) Products LLC | 2015-12-04 |
| 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended recall (Z-0219-2015) | Synthes, Inc. | 2014-11-14 |
| Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) recall (Z-0474-2014) | Synthes USA HQ, Inc. | 2013-12-10 |
| Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable frac recall (Z-0452-2014) | Synthes USA HQ, Inc. | 2013-12-05 |
| Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compr recall (Z-0387-2014) | Synthes USA HQ, Inc. | 2013-11-25 |
| Synthes Trauma Nail System. The devices are indication for bone fixation. recall (Z-2058-2013) | Synthes USA HQ, Inc. | 2013-08-26 |
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 |