The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Fixation Post.
| Device ID | K924514 |
| 510k Number | K924514 |
| Device Name: | ACUFEX FIXATION POST |
| Classification | Screw, Fixation, Bone |
| Applicant | ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Lynne Aronson |
| Correspondent | Lynne Aronson ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-04 |
| Decision Date | 1992-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556595879 | K924514 | 000 |
| 03596010001320 | K924514 | 000 |
| 03596010024664 | K924514 | 000 |
| 03596010024671 | K924514 | 000 |
| 03596010024688 | K924514 | 000 |
| 03596010024695 | K924514 | 000 |
| 03596010024701 | K924514 | 000 |
| 03596010024718 | K924514 | 000 |
| 03596010024725 | K924514 | 000 |
| 03596010024732 | K924514 | 000 |
| 03596010650580 | K924514 | 000 |
| 03596010650597 | K924514 | 000 |
| 03596010650603 | K924514 | 000 |
| 03596010650665 | K924514 | 000 |
| 03596010650672 | K924514 | 000 |
| 03596010650689 | K924514 | 000 |
| 03596010650696 | K924514 | 000 |
| 00885556590553 | K924514 | 000 |
| 03596010421494 | K924514 | 000 |