The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Ace 6.5 Mm Bone Screw.
| Device ID | K931652 |
| 510k Number | K931652 |
| Device Name: | ACE 6.5 MM BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
| Contact | Janice Filippelli |
| Correspondent | Janice Filippelli ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-05 |
| Decision Date | 1994-04-28 |