# K984364: Syntec-Taichung Non-Sterile Small Orthopedic Fixation System, Model 71100, 294-300,400 & 292-730/820

- Pathway: 510(k) (Traditional)
- Applicant: Syntec Scientific Corp.
- Decided: Mar 2, 1999 after 85 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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) Electro-Biology - EBI Small External Fixator (S/E/F/): named in the summary without a submission number

## Indications for use
The Small Orthopedic Fixation System is provided non-sterile. The implants by the External Fixation Instrument may be used for highly comminuted closed fracture of hand, wrist, foot and tarsus ; for severe open fractures; for complex soft-tissue damages; or for dislocated joint fractures.

Source page: https://510kreport.com/device/K984364
Methodology: https://510kreport.com/methodology