Malcolm-Rand Microneurosurgical Cranio-Xray Frame

by Engineered Orthopedic Technologies, Inc. 510(k)

Active United States

510(k) K874298

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK874298	Date4 Feb 1988Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number: K874298
FDA Product Code: HBL

Device Class: Class II
Regulation: 21 CFR Part 882.4460
Advisory Committee: Neurology
FDA Decision: SESE Substantially Equivalent

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