The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Orthopedic Screw Fixation.
Device ID | K932350 |
510k Number | K932350 |
Device Name: | ORTHOPEDIC SCREW FIXATION |
Classification | Screw, Fixation, Bone |
Applicant | OSTEOMED CORP. 2753 FREEMAN ST. Fort Wayne, IN 46802 |
Contact | Billy Darmawan |
Correspondent | Billy Darmawan OSTEOMED CORP. 2753 FREEMAN ST. Fort Wayne, IN 46802 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-14 |
Decision Date | 1995-07-05 |