FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
SMR Hybrid Glenoid System
K Number: K163397
·
Decision Jun 29, 2017
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
34
Applicant Total
13
Review Days
206
Basic Information
- Device Name
- SMR Hybrid Glenoid System
- K Number
- K163397
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3670
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Limacorporate S.p.A.
- Date Received
- December 5, 2016
- Decision Date
- June 29, 2017
- Product Code
- MBF
- 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 |
|---|---|---|---|
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | FDA class 2 | Orthopedic |
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