510(k) K101859
K101859 is an FDA 510(k) premarket notification submitted by Rizzoli Ortopedica S.P.A. for the device "REL-K ARTIFICAL LIMB PROSTHESIS". The FDA issued a decision of Substantially Equivalent on October 13, 2010. The device falls under product code ISY (Joint, Knee, External Limb Component), a Class I device regulated under 21 CFR 890.3420.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2010
- Date Received
- July 2, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Joint, Knee, External Limb Component
- Device Class
- Class I
- Regulation Number
- 890.3420
- Review Panel
- PM
- Submission Type