The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Telescopic Plate Spacer Thoracolumbar (tps-tl) Spinal, Model 8119, 8120, 8130, 8131.
| Device ID | K010989 |
| 510k Number | K010989 |
| Device Name: | TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131 |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Lynn R Rodarti |
| Correspondent | Lynn R Rodarti INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-03 |
| Decision Date | 2001-11-07 |