The following data is part of a premarket notification filed by Hdc S.r.l. with the FDA for Hdc Sterile Spider Screw.
| Device ID | K071851 |
| 510k Number | K071851 |
| Device Name: | HDC STERILE SPIDER SCREW |
| Classification | Implant, Endosseous, Root-form |
| Applicant | HDC S.R.L. VIA CALINDRI, 50 San Lazzaro Di Savena, Bologna, IT 40068 |
| Contact | Guido Bonapace |
| Correspondent | Guido Bonapace HDC S.R.L. VIA CALINDRI, 50 San Lazzaro Di Savena, Bologna, IT 40068 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-05 |
| Decision Date | 2007-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057013140690 | K071851 | 000 |
| 08057013140546 | K071851 | 000 |
| 08057013140539 | K071851 | 000 |
| 08057013140522 | K071851 | 000 |
| 08057013140515 | K071851 | 000 |
| 08057013140508 | K071851 | 000 |
| 08057013140485 | K071851 | 000 |
| 08057013140478 | K071851 | 000 |
| 08057013140461 | K071851 | 000 |
| 08057013140454 | K071851 | 000 |
| 08057013140553 | K071851 | 000 |
| 08057013140560 | K071851 | 000 |
| 08057013140683 | K071851 | 000 |
| 08057013140676 | K071851 | 000 |
| 08057013140669 | K071851 | 000 |
| 08057013140652 | K071851 | 000 |
| 08057013140645 | K071851 | 000 |
| 08057013140614 | K071851 | 000 |
| 08057013140607 | K071851 | 000 |
| 08057013140591 | K071851 | 000 |
| 08057013140584 | K071851 | 000 |
| 08057013140447 | K071851 | 000 |