# K964416: Synthes (U.S.a.)Universal Spinal Parellel Connector the Universal Spinal Rod and Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 17, 1997 after 164 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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) Acromed Kaneda SR (Smooth Rod) Anterior Spinal System: named in the summary without a submission number

## Indications for use
The SYNTHBES (USA) Universal Spinal Paralle] Connector is part of the Universal Rod and Screw Fixation System and is intended for anterolateral screw/staple fixation for the correction of anterolateral lordotic deformities of the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine, (levels T8-LS).

Source page: https://510kreport.com/device/K964416
Methodology: https://510kreport.com/methodology