The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Ace/fisher External Fixator.
| Device ID | K842768 |
| 510k Number | K842768 |
| Device Name: | ACE/FISHER EXTERNAL FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | BUCKMAN CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-16 |
| Decision Date | 1984-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868070488 | K842768 | 000 |