FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VHS SUPRACONDYLAR PLATE SYSTEM
K Number: K991806
·
Decision Aug 6, 1999
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
5
Review Days
72
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Basic Information
- Device Name
- VHS SUPRACONDYLAR PLATE SYSTEM
- K Number
- K991806
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Walter Abendschein, M.D.
- Date Received
- May 26, 1999
- Decision Date
- August 6, 1999
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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Other Clearances by Walter Abendschein, M.D.
| K Number | Device Name | ||
|---|---|---|---|
| K011603 | VHS PEDIATRIC HIP SCREW SYSTEM | Aug 15, 2001 | Substantially Equivalent |
| K002184 | COD COMPRESSION OSTEOTOMY DEVICE | Nov 24, 2000 | Substantially Equivalent |
| K000827 | UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED | Jun 23, 2000 | Substantially Equivalent |
| K964880 | VARI-ANGLE HIP SCREW (VHS) SYSTEM | Oct 16, 1997 | Substantially Equivalent |