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 |