FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEAPLAZA FRAME
K Number: K922238
·
Decision Dec 23, 1992
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
10
Review Days
224
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Basic Information
- Device Name
- LEAPLAZA FRAME
- K Number
- K922238
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Spintech, Inc.
- Date Received
- May 13, 1992
- Decision Date
- December 23, 1992
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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