K801594 is an FDA 510(k) clearance for the ACE FISCHER EXTERNAL FIXATION DEVICE. This device is classified as a Holder, Needle; Orthopedic (Class I - General Controls, product code HXK).
Submitted by Ace Orthopedic Manufacturing Co. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980, 57 days after receiving the submission on July 14, 1980.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K801594 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1980 |
| Decision Date | September 09, 1980 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HXK — Holder, Needle; Orthopedic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |