510(k) K131277
K131277 is an FDA 510(k) premarket notification submitted by Ingen Orthopedics, LLC for the device "SEVIIN FRACTURE SHOULDER". The FDA issued a decision of Substantially Equivalent on August 28, 2013. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Ingen Orthopedics, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2013
- Date Received
- May 6, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device Class
- Class II
- Regulation Number
- 888.3660
- Review Panel
- OR
- Submission Type