The following data is part of a premarket notification filed by Zimmer Spine, Inc with the FDA for Dynesys Spinal System With Ha Coated Screws.
| Device ID | K060638 |
| 510k Number | K060638 |
| Device Name: | DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS |
| Classification | Posterior Metal/polymer Spinal System, Fusion |
| Applicant | ZIMMER SPINE, INC 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2027 |
| Contact | Tim Crabtree |
| Correspondent | Tim Crabtree ZIMMER SPINE, INC 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2027 |
| Product Code | NQP |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-10 |
| Decision Date | 2006-04-06 |
| Summary: | summary |