The following data is part of a premarket notification filed by Onyx Medical Corp. with the FDA for T-plate.
Device ID | K931692 |
510k Number | K931692 |
Device Name: | T-PLATE |
Classification | Plate, Fixation, Bone |
Applicant | ONYX MEDICAL CORP. 152 COLLINS ST. Memphis, TN 38112 |
Contact | Laraine B Gilmore |
Correspondent | Laraine B Gilmore ONYX MEDICAL CORP. 152 COLLINS ST. Memphis, TN 38112 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-05 |
Decision Date | 1994-05-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() T-PLATE 75506830 2470047 Dead/Cancelled |
Ano-Coil Corporation 1998-06-22 |