The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Traxis Cement Restrictor.
| Device ID | K031318 |
| 510k Number | K031318 |
| Device Name: | TRAXIS CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | SPINAL CONCEPTS, INC. 5301 RIATA PARK CT., BLDG. F Austin, TX 78727 |
| Contact | Lisa Peterson |
| Correspondent | Lisa Peterson SPINAL CONCEPTS, INC. 5301 RIATA PARK CT., BLDG. F Austin, TX 78727 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-25 |
| Decision Date | 2003-08-22 |
| Summary: | summary |