510(k) K112983
K112983 is an FDA 510(k) premarket notification submitted by Tecres S.P.A. for the device "SPACER-S". The FDA issued a decision of Substantially Equivalent on December 12, 2011. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Tecres S.P.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2011
- Date Received
- October 6, 2011
- 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