510(k) K982951
K982951 is an FDA 510(k) premarket notification submitted by Imtec Corp. for the device "IMTEC BIOPIN". The FDA issued a decision of Substantially Equivalent on June 21, 1999. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. Imtec Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1999
- Date Received
- August 24, 1998
- 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