The following data is part of a premarket notification filed by Osteomed with the FDA for Osteomed Extremilock Wrist Plating System.
Device ID | K152145 |
510k Number | K152145 |
Device Name: | OsteoMed ExtremiLOCK Wrist Plating System |
Classification | Plate, Fixation, Bone |
Applicant | OSTEOMED 3885 Arapaho Rd Addison, TX 75001 |
Contact | Piedad Pena |
Correspondent | Piedad Pena OSTEOMED 3885 Arapaho Rd Addison, TX 75001 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-03 |
Decision Date | 2015-12-21 |