510(k) K010551
K010551 is an FDA 510(k) premarket notification submitted by Ebi, L.P. for the device "EBI DYNAFIX VS OSTEOTOMY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 17, 2001. The device falls under product code NDF (Plate, Fixation, Bone, Non-Spinal, Metallic), a Class II device regulated under 21 CFR 888.3030. Ebi, L.P. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2001
- Date Received
- February 26, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone, Non-Spinal, Metallic
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type