FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACE INTRAMEDULLARY ROD FOR SMALL BONES
K Number: K850142
·
Decision Feb 7, 1985
Classifications
1
FEI Numbers
295
Registration Numbers
295
Same Product Code
505
Applicant Total
111
Review Days
24
Basic Information
- Device Name
- ACE INTRAMEDULLARY ROD FOR SMALL BONES
- K Number
- K850142
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- BUCKMAN CO., INC.
- Date Received
- January 14, 1985
- Decision Date
- February 7, 1985
- 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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