510(k) K111799
K111799 is an FDA 510(k) premarket notification submitted by Ascension Orthopedic for the device "NUGAIT(TM) SUBTALAR IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on August 19, 2011. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Ascension Orthopedic has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2011
- Date Received
- June 27, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type