FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
GO UNIVERSALK-WIRE FLUTED DRILL
K Number: K954543
·
Decision Dec 8, 1995
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
2
Review Days
71
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Basic Information
- Device Name
- GO UNIVERSALK-WIRE FLUTED DRILL
- K Number
- K954543
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Genesis Orthopedics, Inc.
- Date Received
- September 28, 1995
- Decision Date
- December 8, 1995
- 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 Genesis Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954511 | GO INTRAMEDULLARY NAIL LOCKING SCREW | Dec 19, 1995 | Substantially Equivalent for Some Indications |