FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECICE Intramedullary Limb Lengthening System
K Number: K160325
·
Decision Apr 4, 2016
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
13
Review Days
59
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Basic Information
- Device Name
- PRECICE Intramedullary Limb Lengthening System
- K Number
- K160325
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ellipse Technologies, Inc.
- Date Received
- February 5, 2016
- Decision Date
- April 4, 2016
- 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 Ellipse Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K141278 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | Mar 24, 2015 | Substantially Equivalent |
| K141739 | RESIDUAL LIMB LENGTHENING SYSTEM | Oct 7, 2014 | Substantially Equivalent |
| K140613 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | Sep 18, 2014 | Substantially Equivalent |
| K141447 | PRECICE TRAUMA NAIL SYSTEM | Jun 30, 2014 | Substantially Equivalent |
| K141023 | PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | May 20, 2014 | Substantially Equivalent |
| K140178 | ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | Feb 27, 2014 | Substantially Equivalent |
| K131490 | ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | Jan 23, 2014 | Substantially Equivalent |
| K133289 | PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | Dec 9, 2013 | Substantially Equivalent |
| K131677 | PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | Oct 11, 2013 | Substantially Equivalent |
| K113219 | ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | Oct 19, 2012 | Substantially Equivalent |