FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERTOS MEDICAL MILD DEVICE KIT
K Number: K093062
·
Decision Feb 4, 2010
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
2
Review Days
127
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Basic Information
- Device Name
- VERTOS MEDICAL MILD DEVICE KIT
- K Number
- K093062
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- X-Sten Corp.
- Date Received
- September 30, 2009
- Decision Date
- February 4, 2010
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by X-Sten Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K062038 | X-STEN MILD TOOL KIT, MODEL MTK-0001 | Dec 19, 2006 | Substantially Equivalent |