# K984602: Syntec-Taichung Non-Sterile Unreamed Interlocking Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Syntec Scientific Corp.
- Decided: Mar 5, 1999 after 67 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) Synthes—Titanium Unreamed Femoral Nail: named in the summary without a submission number

## Indications for use
The Unreamed Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(femur, and tibia) for the fixation of fractures.

Source page: https://510kreport.com/device/K984602
Methodology: https://510kreport.com/methodology