The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acumed Pelvic Bone Plate System.
Device ID | K122538 |
510k Number | K122538 |
Device Name: | ACUMED PELVIC BONE PLATE SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124 |
Contact | Kara Budor |
Correspondent | Kara Budor ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-08-21 |
Decision Date | 2012-11-19 |
Summary: | summary |