FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
K Number: K061451
·
Decision Aug 11, 2006
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
25
Applicant Total
22
Review Days
78
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Basic Information
- Device Name
- ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
- K Number
- K061451
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3770
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ascension Orthopedics, Inc.
- Date Received
- May 25, 2006
- Decision Date
- August 11, 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 |
Similar 510(k) Clearances
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Other Clearances by Ascension Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233674 | Freedom Wrist Arthroplasty System | May 30, 2024 | Substantially Equivalent |
| K233670 | Ascension Silicone MCP; Ascension Silicone PIP | Dec 14, 2023 | Substantially Equivalent |
| K121826 | INTEGRA PROXIMAL HUMERAL PLATE SYSTEM | Feb 13, 2013 | Substantially Equivalent |
| K110700 | ASCENSION ATLAS HUMERAL PLATING SYSTEM | Dec 6, 2011 | Substantially Equivalent |
| K102549 | THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY | Dec 21, 2010 | Substantially Equivalent |
| K100448 | ASCENSION MODULAR TOTAL SHOULDER SYSTEM | Aug 30, 2010 | Substantially Equivalent |
| K100502 | ASCENSION TOTAL PLATE SYSTEM | Aug 2, 2010 | Substantially Equivalent |
| K100925 | ASCENSION ANKLE FUSION NAIL SYSTEM | Jul 12, 2010 | Substantially Equivalent |
| K100176 | ASCENSION ANKLE FUSION PLATE SYSTEM | Jun 16, 2010 | Substantially Equivalent |
| K092047 | ASCENSION METAL GREAT TOE SYSTEM | Jan 14, 2010 | Substantially Equivalent |