510(k) K170968
K170968 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "PROPHECY INVISION Pre-operative Navigation System". The FDA issued a decision of Substantially Equivalent on Aug 16, 2017. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Wrightmedicaltechnologyinc has 301 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 16, 2017
- Date Received
- Mar 31, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3110
- Review Panel
- OR
- Submission Type
- 510(k)