The following data is part of a premarket notification filed by Centerpulse Spine-tech, Inc. with the FDA for Dynesys Spinal System.
| Device ID | K031511 |
| 510k Number | K031511 |
| Device Name: | DYNESYS SPINAL SYSTEM |
| Classification | Posterior Metal/polymer Spinal System, Fusion |
| Applicant | CENTERPULSE SPINE-TECH, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2027 |
| Contact | Angela Byland |
| Correspondent | Alex Pawlowski CENTERPULSE SPINE-TECH, INC. 10225 Westmoor Dr. Westminster, CO 80021 |
| Product Code | NQP |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-14 |
| Decision Date | 2004-03-05 |
| Summary: | summary |