The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Quickfix.
Device ID | K962774 |
510k Number | K962774 |
Device Name: | OSTEOMED QUICKFIX |
Classification | Screw, Fixation, Intraosseous |
Applicant | OSTEOMED CORP. 3150 PREMIER DR. #110 Irving, TX 75063 |
Contact | James D Lafferty |
Correspondent | James D Lafferty OSTEOMED CORP. 3150 PREMIER DR. #110 Irving, TX 75063 |
Product Code | DZL |
CFR Regulation Number | 872.4880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-16 |
Decision Date | 1997-10-10 |