The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Ace Cannulated Self Tapping Cancellous Bone Screw.
| Device ID | K903810 |
| 510k Number | K903810 |
| Device Name: | ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ACE MEDICAL CO. C/O BUCKMAN CO., INC. 1000 BURNETTE AVE., SUITE 250 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf ACE MEDICAL CO. C/O BUCKMAN CO., INC. 1000 BURNETTE AVE., SUITE 250 Concord, CA 94520 |
| 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 | 1990-08-20 |
| Decision Date | 1990-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868042270 | K903810 | 000 |
| 00887868042263 | K903810 | 000 |
| 00887868042256 | K903810 | 000 |
| 00887868042249 | K903810 | 000 |
| 00887868042232 | K903810 | 000 |
| 00887868042225 | K903810 | 000 |
| 10705034034614 | K903810 | 000 |