# K930657: D-C-S System

- Pathway: 510(k) (Traditional)
- Applicant: Pina-Vertriebs
- Decided: Jun 29, 1994 after 505 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- 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) Halifax Spinal Clamp System: named in the summary without a submission number

## Indications for use
The D-C-S System is intended for use in the treatment of fracture, deformity, spondylolisthesis, spinal stenosis, tumors and metastases, spondylitis, and spine. It is intended for use in stabilization of the cervical spine (C1-C7) multi-operated using a posterior surgical approach. The implant is intended to be removed from the cervical spine once stabilization or correction is achieved.

Source page: https://510kreport.com/device/K930657
Methodology: https://510kreport.com/methodology