Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal
FDA 510(k) clearance K162697 · decided 2017-02-10
Clearance details
- K-number
- K162697
- Device name
- Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal
- Applicant
- Custom Orthopaedic Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-09-27
- Decision date
- 2017-02-10
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- KWS
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.