The following data is part of a premarket notification filed by Zimmer Spine, Inc with the FDA for Universal Clamp Stainless Steel System, Models Sna027-0-30060, Sna027-0-30063.
| Device ID | K091190 |
| 510k Number | K091190 |
| Device Name: | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 |
| Classification | Cerclage, Fixation |
| Applicant | ZIMMER SPINE, INC 5301 RIATA PARK COURT BUILDING F Austin, TX 78727 |
| Contact | Heather Crawford |
| Correspondent | Heather Crawford ZIMMER SPINE, INC 5301 RIATA PARK COURT BUILDING F Austin, TX 78727 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-23 |
| Decision Date | 2009-07-30 |
| Summary: | summary |