K882407 is an FDA 510(k) clearance for the BOW & ARROW DRILL GUIDE. This device is classified as a Guide, Drill, Ligament (Class I - General Controls, product code LXI).
Submitted by Instrument Makar, Inc. (Okemos, US). The FDA issued a Cleared decision on September 6, 1988, 88 days after receiving the submission on June 10, 1988.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K882407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 1988 |
| Decision Date | September 06, 1988 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LXI — Guide, Drill, Ligament |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |