FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MECTA-C
K Number: K112862
·
Decision Dec 19, 2011
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
39
Review Days
80
Basic Information
- Device Name
- MECTA-C
- K Number
- K112862
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta International
- Date Received
- September 30, 2011
- Decision Date
- December 19, 2011
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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