Reherniation Reduction Device

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

Classification

FDA Product Code: QES
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

The device is intended to reduce the incidence of reherniation, and reoperation following primary limited lumbar discectomy procedures (excision of herniated intervertebral disc).

Market data

Cleared 510(k) submissions: 0
Registered establishments: 2

Source

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