# K963026: TBD

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Oct 28, 1996 after 84 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Smith & Nephew Richards’ Russell-Taylor Humeral Interlocking Nail: named in the summary without a submission number

Source page: https://510kreport.com/device/K963026
Methodology: https://510kreport.com/methodology