The following data is part of a premarket notification filed by Hdc S.r.l. with the FDA for Hdc Spider Screw.
| Device ID | K052471 |
| 510k Number | K052471 |
| Device Name: | HDC SPIDER SCREW |
| Classification | Implant, Endosseous, Root-form |
| Applicant | HDC S.R.L. 6512 BANNOCKBURN DRIVE Bethesda, MD 20817 |
| Contact | Millie Lynn Bentley |
| Correspondent | Millie Lynn Bentley HDC S.R.L. 6512 BANNOCKBURN DRIVE Bethesda, MD 20817 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-08 |
| Decision Date | 2005-12-23 |
| Summary: | summary |