Prosthesis, Spinous Process Tension Band Implant

SGK · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: SGK
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: OR
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown