FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
K Number: K063464
·
Decision Mar 9, 2007
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
276
Applicant Total
15
Review Days
113
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Basic Information
- Device Name
- ATLAS SPINE VERTEBRAL BODY REPLACEMENT
- K Number
- K063464
- 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, Inc.
- Date Received
- November 16, 2006
- Decision Date
- March 9, 2007
- 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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| K182418 | V3 Segmental Plating System | Nov 29, 2018 | Substantially Equivalent |
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| K172334 | Ortus Expandable Lumbar Interbody Fusion System | Oct 25, 2017 | Substantially Equivalent |
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| K112759 | APCLO PEDICLE SCREW SYSTEMS | Oct 18, 2011 | Substantially Equivalent |