The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Ace Cortical Bone Screw.
| Device ID | K912598 |
| 510k Number | K912598 |
| Device Name: | ACE CORTICAL BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles, CA 90061 |
| Contact | Gloria Teske |
| Correspondent | Gloria Teske 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 | 1991-06-10 |
| Decision Date | 1991-11-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868033902 | K912598 | 000 |
| 00887868004681 | K912598 | 000 |
| 00887868004674 | K912598 | 000 |
| 00887868033995 | K912598 | 000 |
| 00887868033988 | K912598 | 000 |
| 00887868033971 | K912598 | 000 |
| 00887868033964 | K912598 | 000 |
| 00887868033957 | K912598 | 000 |
| 00887868033940 | K912598 | 000 |
| 00887868033933 | K912598 | 000 |
| 00887868033926 | K912598 | 000 |
| 00887868004698 | K912598 | 000 |
| 00887868004704 | K912598 | 000 |
| 00887868033896 | K912598 | 000 |
| 00887868033889 | K912598 | 000 |
| 00887868004780 | K912598 | 000 |
| 00887868004773 | K912598 | 000 |
| 00887868004766 | K912598 | 000 |
| 00887868004759 | K912598 | 000 |
| 00887868004742 | K912598 | 000 |
| 00887868004735 | K912598 | 000 |
| 00887868004728 | K912598 | 000 |
| 00887868004711 | K912598 | 000 |
| 00887868033919 | K912598 | 000 |