510(k) K142534
K142534 is an FDA 510(k) premarket notification submitted by Graham Medical Technologies, LLC Dba Gramedica for the device "HyProCure II". The FDA issued a decision of Substantially Equivalent on Oct 3, 2014. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Graham Medical Technologies, LLC Dba Gramedica has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 3, 2014
- Date Received
- Sep 9, 2014
- 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
- 510(k)