510(k) K093599
K093599 is an FDA 510(k) premarket notification submitted by Fournitures Hospitalieres Industrie for the device "ARROW ANATOMICAL SHOULDER SYSTEM". The FDA issued a decision of Substantially Equivalent on Nov 24, 2010. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Fournitures Hospitalieres Industrie has 23 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 24, 2010
- Date Received
- Nov 20, 2009
- 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
- 510(k)