510(k) K101913
K101913 is an FDA 510(k) premarket notification submitted by Anthogyr Sas for the device "ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM". The FDA issued a decision of Substantially Equivalent on March 11, 2011. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Anthogyr Sas has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2011
- Date Received
- July 8, 2010
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type