The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Modification To Synergy Spinal System.
| Device ID | K010515 |
| 510k Number | K010515 |
| Device Name: | MODIFICATION TO SYNERGY SPINAL SYSTEM |
| 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 |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-22 |
| Decision Date | 2001-03-22 |