FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISOELASTICU
K Number: K081025
·
Decision Nov 21, 2008
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
15
Applicant Total
1
Review Days
225
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Basic Information
- Device Name
- ISOELASTICU
- K Number
- K081025
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3810
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Remi Sciences, Inc.
- Date Received
- April 10, 2008
- Decision Date
- November 21, 2008
- Product Code
- KXE
- 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 |
|---|---|---|---|
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | FDA class 2 | Orthopedic |
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