The following data is part of a premarket notification filed by U.s. Spinal Technologies, Llc. with the FDA for Ltd Polyaxial Fixation System.
| Device ID | K041625 |
| 510k Number | K041625 |
| Device Name: | LTD POLYAXIAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | U.S. SPINAL TECHNOLOGIES, LLC. PO BOX 560 Still Water, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan U.S. SPINAL TECHNOLOGIES, LLC. PO BOX 560 Still Water, MN 55082 |
| Product Code | KWQ |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-15 |
| Decision Date | 2004-09-08 |
| Summary: | summary |