FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASCENSION ANKLE FUSION NAIL SYSTEM
K Number: K100925
·
Decision Jul 12, 2010
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
22
Review Days
101
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Basic Information
- Device Name
- ASCENSION ANKLE FUSION NAIL SYSTEM
- K Number
- K100925
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ascension Orthopedics, Inc.
- Date Received
- April 2, 2010
- Decision Date
- July 12, 2010
- 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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|---|---|---|---|
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| K121826 | INTEGRA PROXIMAL HUMERAL PLATE SYSTEM | Feb 13, 2013 | Substantially Equivalent |
| K110700 | ASCENSION ATLAS HUMERAL PLATING SYSTEM | Dec 6, 2011 | Substantially Equivalent |
| K102549 | THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY | Dec 21, 2010 | Substantially Equivalent |
| K100448 | ASCENSION MODULAR TOTAL SHOULDER SYSTEM | Aug 30, 2010 | Substantially Equivalent |
| K100502 | ASCENSION TOTAL PLATE SYSTEM | Aug 2, 2010 | Substantially Equivalent |
| K100176 | ASCENSION ANKLE FUSION PLATE SYSTEM | Jun 16, 2010 | Substantially Equivalent |
| K092047 | ASCENSION METAL GREAT TOE SYSTEM | Jan 14, 2010 | Substantially Equivalent |
| K092440 | ASCENSION CANNULATED SCREW SYSTEM | Nov 5, 2009 | Substantially Equivalent |