The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Imz Bone Tack System.
| Device ID | K952167 |
| 510k Number | K952167 |
| Device Name: | IMZ BONE TACK SYSTEM |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | INTERPORE INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | David Balding |
| Correspondent | David Balding INTERPORE INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-08 |
| Decision Date | 1995-11-21 |