K881378 is an FDA 510(k) clearance for the PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE. This device is classified as a Guide, Drill, Ligament (Class I - General Controls, product code LXI).
Submitted by Pfizer, Inc. (Groton, US). The FDA issued a Cleared decision on June 17, 1988, 77 days after receiving the submission on April 1, 1988.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K881378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 1988 |
| Decision Date | June 17, 1988 |
| Days to Decision | 77 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 |