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

Posterior Metal/Polymer Spinal System, Fusion

21 CFR 888.3070 / Orthopedic
FDA source (opens on fda.gov)

NQP is the FDA product code for Posterior Metal/Polymer Spinal System, Fusion, a class II device type, regulated under 21 CFR 888.3070. FDA's definition for this code reads: "This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine". As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and 50 recalls.

Classification record

Product code
NQP
Device name
Posterior Metal/Polymer Spinal System, Fusion
FDA definition
This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
22
Ingested recalls
50

Clearances, product code NQP

By decision year
22 clearances under product code NQP with a decision year between 2004 and 2021, 2008 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code NQP by decision year
YearClearances
20041
20051
20063
20072
20086
20093
20102
20141
20192
20211

Applicants with the most clearances

Product code NQP
Applicants holding the most 510(k) clearances under product code NQP
ApplicantClearances
Zimmer Spine, Inc.7
Paradigm Spine GmbH5
Medtronic Sofamor Danek USA Inc3
N Spine, Inc.2
Biospine Co., Ltd.1
Centerpulse Spine-Tech, Inc.1
Globus Medical, Inc.1
Medtronic Sofamor Danek1
Scient'X1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order