510(k) K974817
K974817 is an FDA 510(k) premarket notification submitted by Doctor'S Research Group, Inc. for the device "DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM". The FDA issued a decision of Substantially Equivalent on March 13, 1998. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. Doctor'S Research Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1998
- Date Received
- December 23, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Intraosseous
- Device Class
- Class II
- Regulation Number
- 872.4880
- Review Panel
- DE
- Submission Type