K860018 is an FDA 510(k) clearance for the FISCHER WIRE/PIN CLAMP. This device is classified as a Holder, Needle; Orthopedic (Class I - General Controls, product code HXK).
Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on February 7, 1986, 35 days after receiving the submission on January 3, 1986.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K860018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 1986 |
| Decision Date | February 07, 1986 |
| Days to Decision | 35 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 |