FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: OASYS SYSTEM
K Number: K101183
·
Decision Nov 9, 2010
Classifications
1
FEI Numbers
330
Registration Numbers
330
Same Product Code
429
Applicant Total
64
Review Days
195
Basic Information
- Device Name
- MODIFICATION TO: OASYS SYSTEM
- K Number
- K101183
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STRYKER SPINE
- Date Received
- April 28, 2010
- Decision Date
- November 9, 2010
- 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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