FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Precice Intramedullary Limb Lengthening System
K Number: K220234
·
Decision Mar 15, 2023
Classifications
1
FEI Numbers
295
Registration Numbers
295
Same Product Code
505
Applicant Total
19
Review Days
412
Basic Information
- Device Name
- Precice Intramedullary Limb Lengthening System
- K Number
- K220234
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NuVasive Specialized Orthopedics, Inc.
- Date Received
- January 27, 2022
- Decision Date
- March 15, 2023
- Product Code
- HSB
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
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Other Clearances by NuVasive Specialized Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K230765 | Precice Ankle Salvage System | Aug 29, 2023 | Substantially Equivalent |
| K202348 | External Remote Controller ERC 4P | Dec 22, 2020 | Substantially Equivalent |
| K200430 | Precice® Ankle Salvage System | Sep 16, 2020 | Substantially Equivalent |
| K201567 | Precice® Bone Transport System | Aug 10, 2020 | Substantially Equivalent |
| K201543 | MAGEC® System | Jul 30, 2020 | Substantially Equivalent |
| K193617 | Precice® Screws | May 8, 2020 | Substantially Equivalent |
| K193016 | PRECICE Bone Transport System | May 8, 2020 | Substantially Equivalent |
| K192181 | PRECICE Plating System | Nov 7, 2019 | Substantially Equivalent |
| K191336 | PRECICE System | Sep 26, 2019 | Substantially Equivalent |
| K182170 | PRECICE® BONE TRANSPORT System | Feb 5, 2019 | Substantially Equivalent |