K864929 is an FDA 510(k) clearance for the HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST. This device is classified as a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I - General Controls, product code HWE).
Submitted by Hall Surgical, Division of Zimmer, Inc. (`Anta Barbara, US). The FDA issued a Cleared decision on January 28, 1987, 43 days after receiving the submission on December 16, 1986.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K864929 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 1986 |
| Decision Date | January 28, 1987 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HWE — Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |