FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL
K Number: K071929
·
Decision Sep 19, 2007
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
14
Review Days
68
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Basic Information
- Device Name
- NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL
- K Number
- K071929
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthosoft, Inc.
- Date Received
- July 13, 2007
- Decision Date
- September 19, 2007
- Product Code
- HAW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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|---|---|---|---|
| K131409 | CAS PSI KNEE SYSTEM | Sep 13, 2013 | Substantially Equivalent |
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| K071714 | NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 | Jul 20, 2007 | Substantially Equivalent |
| K060336 | NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 | Apr 28, 2006 | Substantially Equivalent |
| K043536 | NAVITRACK SYSTEM - S&N IMAGE FREE KNEE | Jan 14, 2005 | Substantially Equivalent |
| K041369 | NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 | Jun 22, 2004 | Substantially Equivalent |
| K032917 | NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE | Oct 21, 2003 | Substantially Equivalent |
| K030827 | NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 | May 23, 2003 | Substantially Equivalent |
| K031156 | NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 | May 9, 2003 | Substantially Equivalent |
| K022364 | NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200 | Feb 4, 2003 | Substantially Equivalent |