510(k) K193038
K193038 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "Comprehensive Shoulder System". The FDA issued a decision of Substantially Equivalent on October 28, 2020. The device falls under product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3670. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2020
- Date Received
- October 31, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3670
- Review Panel
- OR
- Submission Type