SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
FDA 510(k) clearance K123164 · decided 2013-02-15
Clearance details
- K-number
- K123164
- Device name
- SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
- Applicant
- Spinefrontier, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-10-09
- Decision date
- 2013-02-15
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- MNH
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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| Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (K160020) | Captiva Spine | 2016-03-02 |
| Spinal Inner Fixation System (K143013) | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015-12-11 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: recall (Z-1479-2015) | SpineFrontier, Inc. | 2015-04-21 |
| PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation. recall (Z-0624-2014) | SpineFrontier, Inc. | 2014-01-03 |
| PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFus recall (Z-0553-2014) | SpineFrontier, Inc. | 2013-12-20 |
| PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedF recall (Z-0554-2014) | SpineFrontier, Inc. | 2013-12-20 |
| PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFus recall (Z-0555-2014) | SpineFrontier, Inc. | 2013-12-20 |
| PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended recall (Z-0544-2014) | SpineFrontier, Inc. | 2013-12-19 |