K862529 is an FDA 510(k) clearance for the HALL STERILE BUR. This device is classified as a Burr, Orthopedic (Class I - General Controls, product code HTT).
Submitted by Hall Surgical, Division of Zimmer, Inc. (`Anta Barbara, US). The FDA issued a Cleared decision on July 15, 1986, 13 days after receiving the submission on July 2, 1986.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K862529 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 1986 |
| Decision Date | July 15, 1986 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HTT — Burr, Orthopedic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |