SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR
FDA 510(k) clearance K010690 · decided 2001-05-18
Clearance details
- K-number
- K010690
- Device name
- SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 2001-03-08
- Decision date
- 2001-05-18
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- DZL
- Device class
- 2
- Regulation number
- 872.4880
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Paoli, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of recall (Z-1745-2013) | Synthes USA HQ, Inc. | 2013-07-17 |
| Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening recall (Z-0903-2013) | Synthes USA HQ, Inc. | 2013-03-01 |
| Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487. recall (Z-0904-2013) | Synthes USA HQ, Inc. | 2013-03-01 |
| Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487. recall (Z-0905-2013) | Synthes USA HQ, Inc. | 2013-03-01 |
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 |