FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CMC CABLE FIX
K Number: K111032
·
Decision Aug 31, 2011
Classifications
1
FEI Numbers
272
Registration Numbers
272
Same Product Code
92
Applicant Total
10
Review Days
140
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Basic Information
- Device Name
- CMC CABLE FIX
- K Number
- K111032
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instratek, Inc.
- Date Received
- April 13, 2011
- Decision Date
- August 31, 2011
- Product Code
- HTN
- 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 |
|---|---|---|---|
| HTN | Washer, Bolt Nut | FDA class 2 | Orthopedic |
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