SGKClass III

Prosthesis, Spinous Process Tension Band Implant

Unknown

SGK is the FDA product code for Prosthesis, Spinous Process Tension Band Implant, a class III device type. FDA's definition for this code reads: "This device is a non-fusion, tension band implant that is intended to provide dynamic flexion-restricting stabilization of the spine following a lumbar decompression". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: SGK
Device name: Prosthesis, Spinous Process Tension Band Implant
FDA definition: This device is a non-fusion, tension band implant that is intended to provide dynamic flexion-restricting stabilization of the spine following a lumbar decompression.
Device class: Class III
Review panel: Unknown
Submission type: PMA
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

Empirical Spine, Inc.

Recent clearances

Product code SGK

FDA records hold no clearances under product code SGK.

Recent recalls

Product code SGK

FDA records show no recalls under product code SGK.

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)