510(k) K161620
K161620 is an FDA 510(k) premarket notification submitted by Zimmer GmbH for the device "Anatomical Shoulder Domelock Dome centric". The FDA issued a decision of Substantially Equivalent on November 1, 2016. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Zimmer GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2016
- Date Received
- June 13, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3690
- Review Panel
- OR
- Submission Type