FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
OSCAR BONE RESECTOR
K Number: K083830
·
Decision Mar 20, 2009
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
22
Applicant Total
4
Review Days
87
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Basic Information
- Device Name
- OSCAR BONE RESECTOR
- K Number
- K083830
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.4580
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthosonics, Ltd.
- Date Received
- December 23, 2008
- Decision Date
- March 20, 2009
- Product Code
- JDX
- 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 |
|---|---|---|---|
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | FDA class 2 | Orthopedic |
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