510(k) K162179
K162179 is an FDA 510(k) premarket notification submitted by Graham Medical Technologies, LLC Dba Gramedica for the device "osteo-WEDGE II ® Open Wedge Bone Locking Plate System". The FDA issued a decision of Substantially Equivalent on Jan 10, 2017. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Graham Medical Technologies, LLC Dba Gramedica has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 10, 2017
- Date Received
- Aug 4, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)