PRECICE® BONE TRANSPORT™ System
FDA 510(k) clearance K182170 · decided 2019-02-05
Clearance details
- K-number
- K182170
- Device name
- PRECICE® BONE TRANSPORT™ System
- Applicant
- Nuvasive Specialized Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-08-10
- Decision date
- 2019-02-05
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Alisa Viejo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fra recall (Z-1324-2021) | Nuvasive Specialized Orthopedics Inc | 2021-03-30 |