The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Synergy 4.0 Mm, 4.5 Mm Vls Screws.
| Device ID | K011437 |
| 510k Number | K011437 |
| Device Name: | SYNERGY 4.0 MM, 4.5 MM VLS SCREWS |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Lynn Rodarti |
| Correspondent | Lynn Rodarti INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-10 |
| Decision Date | 2001-06-06 |