FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORTHODOC PREOPERATIVE PLANNER MODEL 500
K Number: K960685
·
Decision Jan 17, 1997
Classifications
1
FEI Numbers
434
Registration Numbers
434
Same Product Code
9
Applicant Total
3
Review Days
332
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Basic Information
- Device Name
- ORTHODOC PREOPERATIVE PLANNER MODEL 500
- K Number
- K960685
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4800
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integrated Surgical Systems, Inc.
- Date Received
- February 20, 1996
- Decision Date
- January 17, 1997
- Product Code
- HWT
- 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 |
|---|---|---|---|
| HWT | Template | FDA class 1 | Orthopedic |
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