510(k) K032180
K032180 is an FDA 510(k) premarket notification submitted by Nuvasive, Inc. for the device "NUVASIVE CEMENT RESTRICTOR". The FDA issued a decision of SESU on October 7, 2003. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Nuvasive, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- October 7, 2003
- Date Received
- July 17, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Cement Restrictor
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type