PWGNot classified

Spinal Fixation System

Unknown

PWG is the FDA product code for Spinal Fixation System. FDA's definition for this code reads: "Stabilization of the posterior thoracic and lumbar spine". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PWG
Device name: Spinal Fixation System
FDA definition: Stabilization of the posterior thoracic and lumbar spine
Device class: Not classified
Review panel: Unknown
Submission type: Contact ODE
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

K2M, Inc

Recent clearances

Product code PWG

FDA records hold no clearances under product code PWG.

Recent recalls

Product code PWG

FDA records show no recalls under product code PWG.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)