The following data is part of a premarket notification filed by Osteocentric Technologies with the FDA for Cannulated Fasteners And Nuts.
Device ID | K210754 |
510k Number | K210754 |
Device Name: | Cannulated Fasteners And Nuts |
Classification | Screw, Fixation, Bone |
Applicant | OsteoCentric Technologies 75 West 300 North, Suite #150 Logan, UT 84321 |
Contact | Todd Evans |
Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-03-15 |
Decision Date | 2021-04-14 |