FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRAMEDULLARY NAIL
K Number: K870040
·
Decision Mar 26, 1987
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
9
Review Days
80
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Basic Information
- Device Name
- INTRAMEDULLARY NAIL
- K Number
- K870040
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- The Deca Co.
- Date Received
- January 5, 1987
- Decision Date
- March 26, 1987
- 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 The Deca Co.
| K Number | Device Name | ||
|---|---|---|---|
| K870041 | FLEXIBLE FASCICULATED BONE PLATE | Jul 17, 1987 | Substantially Equivalent |
| K863271 | FASCICULATED S ROD | Dec 24, 1986 | Substantially Equivalent |
| K863215 | FASCICULATED I ROD | Dec 24, 1986 | Substantially Equivalent |
| K863239 | FASCICULATED BOAT ROD | Dec 24, 1986 | Substantially Equivalent |
| K861183 | INTRAMEDULLARY ROD | Aug 11, 1986 | Substantially Equivalent |
| K854227 | FASCILULATED NAIL | Feb 4, 1986 | Substantially Equivalent |
| K830087 | INTRAMEDULLARY ROD | Mar 1, 1983 | Substantially Equivalent |
| K813340 | HIP PIN | Jan 29, 1982 | Substantially Equivalent |