# K962314: Halifax Plus Interlaminar Clamp System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Dec 9, 1996 after 175 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
Longest line of descent: 1 generation back to K850039 (1985). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850039: Halifax Spinal Clamp, Levtech, Inc. (1985) Summary page 1.

## Most influential descendants
- K161032: neon3™  universal OCT spinal stabilization (2016), 7 descendants of its own
- K191932: Momentum™ Posterior Spinal Fixation System (2019), 2 descendants of its own
- K231809: Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement (2023), 1 descendant of its own
- K251719: Momentum® Posterior Spinal Fixation System (2025), 0 descendants of its own
- K221307: Edge Upper Cervical System (2023), 0 descendants of its own

## Indications for use
The subject devices are intended for single use and are indicated for patients with cervical subluxations and dislocations from C1-C7 to achieve posterior cervical stabilization.

Source page: https://510kreport.com/device/K962314
Methodology: https://510kreport.com/methodology
