FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAVA K-WIRE
K Number: K940109
·
Decision Feb 22, 1994
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
7
Review Days
43
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Basic Information
- Device Name
- TAVA K-WIRE
- K Number
- K940109
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tava Surgical Instruments
- Date Received
- January 10, 1994
- Decision Date
- February 22, 1994
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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Other Clearances by Tava Surgical Instruments
| K Number | Device Name | ||
|---|---|---|---|
| K935367 | TAVA WIRE-DRIVER | Apr 21, 1994 | Substantially Equivalent |
| K885273 | MICRO SURGICAL INSTRUMENT SYSTEM | Jan 30, 1989 | Substantially Equivalent |
| K884492 | MICRO SURGICAL INSTRUMENT SYSTEM | Nov 16, 1988 | Substantially Equivalent |
| K872475 | SURGICAL BUR | Jul 2, 1987 | Substantially Equivalent |
| K863788 | SAWBLADE | Oct 14, 1986 | Substantially Equivalent |
| K854543 | PULSE LAVAGE | Jan 27, 1986 | Substantially Equivalent |