The following data is part of a premarket notification filed by Ace Orthopedic Manufacturing Co. with the FDA for Ace Fischer External Fixation Device.
| Device ID | K801594 |
| 510k Number | K801594 |
| Device Name: | ACE FISCHER EXTERNAL FIXATION DEVICE |
| Classification | Holder, Needle; Orthopedic |
| Applicant | ACE ORTHOPEDIC MANUFACTURING CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HXK |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-14 |
| Decision Date | 1980-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868010774 | K801594 | 000 |
| 00887868010767 | K801594 | 000 |
| 00887868003066 | K801594 | 000 |
| 00887868003059 | K801594 | 000 |
| 00887868003042 | K801594 | 000 |
| 00887868003035 | K801594 | 000 |
| 00887868001598 | K801594 | 000 |
| 00887868070495 | K801594 | 000 |