510(k) K043602
K043602 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek for the device "QUADRANT RETRACTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on February 23, 2005. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Medtronic Sofamor Danek has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2005
- Date Received
- December 29, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type