The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Ace Unilateral Fixator.
| Device ID | K860590 |
| 510k Number | K860590 |
| Device Name: | ACE UNILATERAL FIXATOR |
| Classification | Pin, Fixation, Smooth |
| Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-19 |
| Decision Date | 1986-03-07 |