510(k) K905023
K905023 is an FDA 510(k) premarket notification submitted by Advanced Med/Surg, Inc. for the device "AMSET LOCKING PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 31, 1992. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Advanced Med/Surg, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1992
- Date Received
- November 7, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Intervertebral Body
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type