FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROSTHETIC CEMENT REMOVER
K Number: K904180
·
Decision Nov 20, 1990
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
6
Applicant Total
50
Review Days
70
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Basic Information
- Device Name
- PROSTHETIC CEMENT REMOVER
- K Number
- K904180
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.4580
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Origin Medsystems, Inc.
- Date Received
- September 11, 1990
- Decision Date
- November 20, 1990
- Product Code
- LZV
- 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 |
|---|---|---|---|
| LZV | System, Cement Removal Extraction | FDA class 2 | Orthopedic |
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| K965121 | CANNULA | Mar 20, 1997 | Substantially Equivalent |
| K964171 | VASOVIEW BALLOON DISSECTION SYSTEM | Feb 14, 1997 | Substantially Equivalent |
| K962104 | AIRLIFT BALLOON RETRACTON SYSTEM | Sep 11, 1996 | Substantially Equivalent |
| K962005 | EXTRAHAND BALLOON RETRACTOR | Aug 12, 1996 | Substantially Equivalent |
| K960936 | RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES] | Jul 24, 1996 | Substantially Equivalent |
| K960637 | 5MM ENDOSCOPE | Jun 14, 1996 | Substantially Equivalent |