510(k) K031034
K031034 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "SPIN DOWN RAPIDFLAP". The FDA issued a decision of Substantially Equivalent on May 21, 2003. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 2003
- Date Received
- April 1, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Cranioplasty, Preformed, Non-Alterable
- Device Class
- Class II
- Regulation Number
- 882.5330
- Review Panel
- NE
- Submission Type