HDC Sterile Spider Screw
FDA 510(k) K071851 · Hdc S.R.L.
510(k) numberK071851
Submission
- Device name
- HDC Sterile Spider Screw
- Applicant
- Hdc S.R.L.
S. Lazzaro Di Savena, Bologna, IT - Received
- July 5, 2007
- Decision date
- October 18, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was HDC Sterile Spider Screw cleared by the FDA?
HDC Sterile Spider Screw (K071851) received a 510(k) decision of Substantially Equivalent on October 18, 2007, 105 days after the submission was received.
What is the product code of K071851?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.