FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
K Number: K111166
·
Decision Sep 8, 2011
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
4
Review Days
135
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Basic Information
- Device Name
- A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
- K Number
- K111166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spineworks, LLC
- Date Received
- April 26, 2011
- Decision Date
- September 8, 2011
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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