FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
K Number: K123122
·
Decision Apr 5, 2013
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
189
Applicant Total
1
Review Days
183
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Basic Information
- Device Name
- GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
- K Number
- K123122
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cleveland Clinic
- Date Received
- October 4, 2012
- Decision Date
- April 5, 2013
- Product Code
- KWS
- 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 |
|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
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