K802676 is an FDA 510(k) clearance for the ORHTOPEDIC REAMER 87 HTD. This device is classified as a Forceps (Class I - General Controls, product code HTD).
Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980, 14 days after receiving the submission on October 29, 1980.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K802676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 1980 |
| Decision Date | November 12, 1980 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HTD — Forceps |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |