The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Synergy Integral Screws, Model Numbers 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220.
| Device ID | K993808 |
| 510k Number | K993808 |
| Device Name: | SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220 |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Prosie Rey-fessler |
| Correspondent | Prosie Rey-fessler INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | MNH |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-10 |
| Decision Date | 1999-12-06 |
| Summary: | summary |