K892655 is an FDA 510(k) clearance for the ACL DRILL GUIDE SYSTEM. This device is classified as a Guide, Drill, Ligament (Class I - General Controls, product code LXI).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on September 28, 1989, 168 days after receiving the submission on April 13, 1989.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K892655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 1989 |
| Decision Date | September 28, 1989 |
| Days to Decision | 168 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 |