FDA 510(k)
Substantially Equivalent
🇺🇸 United States
FASCICULATED I ROD
K Number: K863215
·
Decision Dec 24, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
9
Review Days
126
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Basic Information
- Device Name
- FASCICULATED I ROD
- K Number
- K863215
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- The Deca Co.
- Date Received
- August 20, 1986
- Decision Date
- December 24, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
Other Clearances by The Deca Co.
| K Number | Device Name | ||
|---|---|---|---|
| K870041 | FLEXIBLE FASCICULATED BONE PLATE | Jul 17, 1987 | Substantially Equivalent |
| K870040 | INTRAMEDULLARY NAIL | Mar 26, 1987 | Substantially Equivalent |
| K863271 | FASCICULATED S 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 |