The following data is part of a premarket notification filed by Ace Orthopedic Manufacturing Co. with the FDA for Ace 100 Degrees Tubular Plate.
Device ID | K920738 |
510k Number | K920738 |
Device Name: | ACE 100 DEGREES TUBULAR PLATE |
Classification | Plate, Fixation, Bone |
Applicant | ACE ORTHOPEDIC MANUFACTURING CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
Contact | Janice L Filippelli |
Correspondent | Janice L Filippelli ACE ORTHOPEDIC MANUFACTURING CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-19 |
Decision Date | 1992-07-27 |