510(k) K050795
K050795 is an FDA 510(k) premarket notification submitted by Orthovita, Inc. for the device "IMBIBE BONE MARROW ASPIRATION NEEDLE". The FDA issued a decision of Substantially Equivalent on June 3, 2005. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Orthovita, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2005
- Date Received
- March 29, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- SU
- Submission Type