510(k) K130185
K130185 is an FDA 510(k) premarket notification submitted by 4-Web, Inc. for the device "4WEB OSTEOTOMY BONE WEDGE". The FDA issued a decision of Substantially Equivalent on June 7, 2013. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. 4-Web, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2013
- Date Received
- January 25, 2013
- 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