FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
G/K SFN AND STN LOCKING NAILS
K Number: K983358
·
Decision Nov 18, 1998
Classifications
1
FEI Numbers
295
Registration Numbers
295
Same Product Code
505
Applicant Total
36
Review Days
55
Basic Information
- Device Name
- G/K SFN AND STN LOCKING NAILS
- K Number
- K983358
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HOWMEDICA, INC.
- Date Received
- September 24, 1998
- Decision Date
- November 18, 1998
- 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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