510(k) K091807
K091807 is an FDA 510(k) premarket notification submitted by Porex Surgical, Inc. for the device "MEDPOR FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 28, 2010. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Porex Surgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2010
- Date Received
- June 18, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type