The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osa Rigid Internal Fixation System.
Device ID | K021618 |
510k Number | K021618 |
Device Name: | OSA RIGID INTERNAL FIXATION SYSTEM |
Classification | Plate, Bone |
Applicant | OSTEOMED CORP. 3750 REALTY RD. Addison, TX 75001 -4311 |
Contact | Dawn T Holdeman |
Correspondent | Dawn T Holdeman OSTEOMED CORP. 3750 REALTY RD. Addison, TX 75001 -4311 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-16 |
Decision Date | 2002-08-08 |
Summary: | summary |