FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
K Number: K061089
·
Decision Jun 20, 2006
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
25
Applicant Total
41
Review Days
63
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Basic Information
- Device Name
- MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
- K Number
- K061089
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3770
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biopro, Inc.
- Date Received
- April 18, 2006
- Decision Date
- June 20, 2006
- Product Code
- KYI
- 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 |
|---|---|---|---|
| KYI | Prosthesis, Wrist, Carpal Trapezium | FDA class 2 | Orthopedic |
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