K811081 is an FDA 510(k) clearance for the MEDULLARY CANAL SCRAPERS. This device is classified as a Reamer (Class I - General Controls, product code HTO).
Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1981, 8 days after receiving the submission on April 21, 1981.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K811081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 1981 |
| Decision Date | April 29, 1981 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HTO — Reamer |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |