The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Synergy Helical Flange Plug, Helical Flange Seat And Helical Flange Reduction Seat.
| Device ID | K041449 |
| 510k Number | K041449 |
| Device Name: | SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Wendy Spielberger |
| Correspondent | Wendy Spielberger 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 | 2004-06-01 |
| Decision Date | 2004-07-01 |
| Summary: | summary |