FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
K Number: K091976
·
Decision Aug 17, 2009
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
7
Review Days
47
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Basic Information
- Device Name
- BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
- K Number
- K091976
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Trauma
- Date Received
- July 1, 2009
- Decision Date
- August 17, 2009
- 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 Biomet Trauma
| K Number | Device Name | ||
|---|---|---|---|
| K092078 | OPTILOCK PERIARTICULAR PLATING | Aug 5, 2009 | Substantially Equivalent |
| K082874 | BIODRIVE CANNULATED SCREW SYSTEM | Feb 5, 2009 | Substantially Equivalent |
| K081244 | LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS | Jul 30, 2008 | Substantially Equivalent |
| K081243 | BIOMET PHOENIX ANKLE NAIL SYSTEM | Jun 27, 2008 | Substantially Equivalent |
| K071325 | BIOMET VARIABLE LOCKING PLATE SYSTEM | Jul 26, 2007 | Substantially Equivalent |
| K070823 | GROWTH CONTROL PLATING SYSTEM | May 7, 2007 | Substantially Equivalent |