510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QESClass III

Reherniation Reduction Device

Unknown
FDA source (opens on fda.gov)

QES is the FDA product code for Reherniation Reduction Device, a class III device type. FDA's definition for this code reads: "The device is intended to reduce the incidence of reherniation, and reoperation following primary limited lumbar discectomy procedures (excision of herniated intervertebral disc)". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
QES
Device name
Reherniation Reduction Device
FDA definition
The device is intended to reduce the incidence of reherniation, and reoperation following primary limited lumbar discectomy procedures (excision of herniated intervertebral disc).
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
1

Companies listing this code with FDA

Companies whose registered establishments list this code