The following data is part of a premarket notification filed by Zimmer Spine with the FDA for Universal Clamp Spinal Fixation System.
| Device ID | K110348 |
| 510k Number | K110348 |
| Device Name: | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | ZIMMER SPINE 7375 BUSH LAKE ROAD Edina, MN 55439 |
| Contact | Elsa A Linke |
| Correspondent | Elsa A Linke ZIMMER SPINE 7375 BUSH LAKE ROAD Edina, MN 55439 |
| Product Code | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-07 |
| Decision Date | 2011-08-11 |
| Summary: | summary |