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

Orthosis, Spine, Plate, Laminoplasty, Metal

21 CFR 888.3050 / Orthopedic
FDA source (opens on fda.gov)

NQW is the FDA product code for Orthosis, Spine, Plate, Laminoplasty, Metal, a class II device type, regulated under 21 CFR 888.3050. FDA's definition for this code reads: "This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure". As of , FDA records hold 30 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NQW
Device name
Orthosis, Spine, Plate, Laminoplasty, Metal
FDA definition
This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.
Regulation
21 CFR 888.3050
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
30
Ingested recalls
0

Clearances, product code NQW

By decision year
30 clearances under product code NQW with a decision year between 2004 and 2026, 2012 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code NQW by decision year
YearClearances
20041
20052
20081
20092
20103
20124
20133
20151
20162
20171
20182
20192
20211
20232
20242
20261

Applicants with the most clearances

Product code NQW
Applicants holding the most 510(k) clearances under product code NQW
ApplicantClearances
Globus Medical, Inc.3
Curiteva, Inc.2
Life Spine2
Medtronic Sofamor Danek2
Seaspine, Inc.2
VY Spine, LLC2
Aesculap Implant System, Inc.1
Aesculap Inc1
Biomet Spine (Aka Ebi, LLC)1
Blackstone Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 60 companies shown, in name order