510(k) K043233
K043233 is an FDA 510(k) premarket notification submitted by Efratgo, Ltd. HI Tech Bio-Surgical for the device "GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL". The FDA issued a decision of Substantially Equivalent on February 1, 2005. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Efratgo, Ltd. HI Tech Bio-Surgical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 2005
- Date Received
- November 22, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rod, Fixation, Intramedullary And Accessories
- Device Class
- Class II
- Regulation Number
- 888.3020
- Review Panel
- OR
- Submission Type