The following data is part of a premarket notification filed by Abbott Spine, Inc. with the FDA for Universal Clamp Stainless Steel System.
| Device ID | K081622 |
| 510k Number | K081622 |
| Device Name: | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | ABBOTT SPINE, INC. 5301 RIATA PARK CT., BLDG. F Austin, TX 78727 |
| Contact | Maritza Elias |
| Correspondent | Maritza Elias ABBOTT SPINE, INC. 5301 RIATA PARK CT., BLDG. 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 | 2008-06-10 |
| Decision Date | 2008-08-29 |
| Summary: | summary |