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 |