FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
K Number: K080024
·
Decision Jan 24, 2008
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
276
Applicant Total
100
Review Days
20
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Basic Information
- Device Name
- ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
- K Number
- K080024
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K2m, Inc.
- Date Received
- January 4, 2008
- Decision Date
- January 24, 2008
- Product Code
- MQP
- 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 |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | FDA class 2 | Orthopedic |
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