The following data is part of a premarket notification filed by Ace Orthopedic Manufacturing Co. with the FDA for Ace 8.0mm Cannulated Cancellous Bone Screw.
| Device ID | K926047 |
| 510k Number | K926047 |
| Device Name: | ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-01 |
| Decision Date | 1993-03-31 |