510(k) K982927
K982927 is an FDA 510(k) premarket notification submitted by Kinamed, Inc. for the device "QUICK TAP SELF DRILLING SCREW". The FDA issued a decision of Substantially Equivalent on September 8, 1998. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. Kinamed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 1998
- Date Received
- August 20, 1998
- Clearance Type
- Special
- 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