FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATLAS SPINE SPACER
K Number: K091406
·
Decision Sep 4, 2009
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
276
Applicant Total
3
Review Days
115
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Basic Information
- Device Name
- ATLAS SPINE SPACER
- K Number
- K091406
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Atlas Spine, LLC
- Date Received
- May 12, 2009
- Decision Date
- September 4, 2009
- 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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