FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIODRIVE CANNULATED SCREW SYSTEM
K Number: K082874
·
Decision Feb 5, 2009
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
7
Review Days
129
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Basic Information
- Device Name
- BIODRIVE CANNULATED SCREW SYSTEM
- K Number
- K082874
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Trauma
- Date Received
- September 29, 2008
- Decision Date
- February 5, 2009
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Biomet Trauma
| K Number | Device Name | ||
|---|---|---|---|
| K091976 | BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL | Aug 17, 2009 | Substantially Equivalent |
| K092078 | OPTILOCK PERIARTICULAR PLATING | Aug 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 |