The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Ace Supracondylar Plate.
| Device ID | K950618 |
| 510k Number | K950618 |
| Device Name: | ACE SUPRACONDYLAR PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen ACE MEDICAL 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 | 1995-02-10 |
| Decision Date | 1995-05-10 |