510(k) K231516
K231516 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "INHANCE Shoulder System, Sterile Single Use Instrumentation". The FDA issued a decision of Substantially Equivalent on July 21, 2023. The device falls under product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3670. Depuy Ireland UC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2023
- Date Received
- May 25, 2023
- 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