The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Spinal Concepts, Inc. Infix System.
| Device ID | K031672 |
| 510k Number | K031672 |
| Device Name: | SPINAL CONCEPTS, INC. INFIX SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| 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 | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-30 |
| Decision Date | 2003-08-07 |
| Summary: | summary |