510(k) K092493
K092493 is an FDA 510(k) premarket notification submitted by Gpc Medical, Ltd. for the device "GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 29, 2010. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Gpc Medical, Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 29, 2010
- Date Received
- Aug 14, 2009
- 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)