FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ODI TALON INTRAMEDULLARY HIP NAIL
K Number: K014189
·
Decision Mar 21, 2002
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
52
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- ODI TALON INTRAMEDULLARY HIP NAIL
- K Number
- K014189
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthopedic Designs, Inc.
- Date Received
- December 21, 2001
- Decision Date
- March 21, 2002
- Product Code
- JDS
- 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 |
|---|---|---|---|
| JDS | Nail, Fixation, Bone | FDA class 2 | Orthopedic |
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