The following data is part of a premarket notification filed by Kronner Medical with the FDA for Skeletal Fixation Pin.
Device ID | K895173 |
510k Number | K895173 |
Device Name: | SKELETAL FIXATION PIN |
Classification | Pin, Fixation, Threaded |
Applicant | KRONNER MEDICAL 544 WEST UMPQUA SUITE 104 Roseburg, OR 97470 |
Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-10 |
Decision Date | 1989-09-12 |