K873711 is an FDA 510(k) clearance for the RETROGRADE KNIFE, DISPOSABLE #TM-1613. This device is classified as a Knife, Orthopedic (Class I - General Controls, product code HTS).
Submitted by Arthropedics, Inc. (Wallington, US). The FDA issued a Cleared decision on November 2, 1987, 48 days after receiving the submission on September 15, 1987.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K873711 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 1987 |
| Decision Date | November 02, 1987 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HTS — Knife, Orthopedic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |