510(k) K014200
K014200 is an FDA 510(k) premarket notification submitted by Spineology, Inc. for the device "OPTIMESH". The FDA issued a decision of SESU on November 26, 2003. The device falls under product code EZX (Mesh, Surgical, Metal), a Class II device regulated under 21 CFR 878.3300. Spineology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- November 26, 2003
- Date Received
- December 21, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Metal
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type