The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Synergy Ti Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177.
| Device ID | K012871 |
| 510k Number | K012871 |
| Device Name: | SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177 |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Lynn M Rodarti |
| Correspondent | Lynn M Rodarti INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-27 |
| Decision Date | 2001-09-13 |
| Summary: | summary |