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

Prosthesis, Posterior Spinal Elements

Unknown
FDA source (opens on fda.gov)

QWK is the FDA product code for Prosthesis, Posterior Spinal Elements, a class III device type. FDA's definition for this code reads: "This device is a non-fusion, load-bearing implanted prosthesis that stabilizes the spine following resection of posterior spinal elements". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
QWK
Device name
Prosthesis, Posterior Spinal Elements
FDA definition
This device is a non-fusion, load-bearing implanted prosthesis that stabilizes the spine following resection of posterior spinal elements.
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