510(k) K071851

HDC STERILE SPIDER SCREW by Hdc S.R.L. — Product Code DZE

K071851 is an FDA 510(k) premarket notification submitted by Hdc S.R.L. for the device "HDC STERILE SPIDER SCREW". The FDA issued a decision of Substantially Equivalent on October 18, 2007. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Hdc S.R.L. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2007
Date Received
July 5, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type