NQW

Product Code: NQW


Products Classified as NQW

4648Orthosis, Spine, Plate, Laminoplasty, MetalSpinal Interlaminal Fixation Orthosis.

Total Product Life Cycle (TPLC) Devices

4648Orthosis, Spine, Plate, Laminoplasty, MetalSpinal Interlaminal Fixation Orthosis.

FDA Consensus Standards

Orthosis, Spine, Plate, Laminoplasty, Metal [37410]21 CFR §888.3050 🔎
Orthosis, Spine, Plate, Laminoplasty, Metal [37411]21 CFR §888.3050 🔎

Pre-market Notifications for NQW

K212428Centerpiece Plate Fixation SystemMedtronic Sofamor Danek
K191927Hinged Laminoplasty SystemLife Spine, Inc.
K191169NuVasive® Camber Laminoplasty SystemNuVasive, Incorporated
K181717Life Spine Laminoplasty SystemLife Spine Inc.
K173215Choice Spine Laminoplasty™ Fixation SystemChoice Spine, LP
K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical Inc.
K160114Xspan Laminoplasty Fixation SystemX-SPINE SYSTEMS, INC.
K153735Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
K150469Integra Laminoplasty SystemSEASPINE, INC.
K132740SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEMSPINEFRONTIER, INC.
K130830INTEGRA LAMINOPLASTY SYSTEMSEASPINE, INC.
K122822SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEMSPECTRUM SPINE, LLC
K121732CANOPY LAMINOPLASTY FIXATION SYSTEMGLOBUS MEDICAL INC.
K121276NEURO VENTION LAMINPLASTY PLATING SYSTEMNEUROVENTION LLC
K113802ESCALATE LAMINOPLASTY SYSTEMSTRYKER SPINE

Global Unique Device Identification Database

00613994866158ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
00613994866141ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
00613994866134ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
00613994866127ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
00613994866110ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
00613994866103ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
00613994866097ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
00613994866080ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
00613994532169ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
00613994532152ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
00613994532145ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
00613994532138ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
00613994532121ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
00613994270825ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
00613994270818ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Maude Adverse Events

CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2019-07-28
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2019-07-28
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2019-07-04
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2019-07-04
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2019-05-22
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2019-05-22
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2019-02-20
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2019-02-20
ORTHOSIS, SPINE, PLATE, LAMINOPLASTY METALOBERDORF SYNTHES PRODUKTIONS GMBH2018-05-18
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2018-03-01
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2018-02-22
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2018-02-16
ESCALATE EXPANDABLE PLATESTRYKER SPINE-US2018-02-06
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2017-12-21
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2017-12-07
CENTERPIECE SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK2017-09-25
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2017-08-10
2.4 X 5.0MM SELF TAPPING SCREWZIMMER BIOMET SPINE INC.2017-06-28
2.4 X 5.0MM SELF TAPPING SCREWZIMMER BIOMET SPINE INC.2017-06-28
2.4 X 5.0MM SELF TAPPING SCREWZIMMER BIOMET SPINE INC.2017-06-28
2.4 X 5.0MM SELF TAPPING SCREWZIMMER BIOMET SPINE INC.2017-06-28
2.4 X 5.0MM SELF TAPPING SCREWZIMMER BIOMET SPINE INC.2017-06-28
2.4 X 5.0MM SELF TAPPING SCREWZIMMER BIOMET SPINE INC.2017-06-28
2.4 X 5.0MM SELF TAPPING SCREWZIMMER BIOMET SPINE INC.2017-06-28
2.4 X 5.0MM SELF TAPPING SCREWZIMMER BIOMET SPINE INC.2017-06-28
2.4 X 5.0MM SELF TAPPING SCREWZIMMER BIOMET SPINE INC.2017-06-28
2.4 X 5.0MM SELF TAPPING SCREWZIMMER BIOMET SPINE INC.2017-06-28
2.4 X 5.0MM SELF TAPPING SCREWZIMMER BIOMET SPINE INC.2017-06-28
2.4 X 5.0MM SELF TAPPING SCREWZIMMER BIOMET SPINE INC.2017-06-07
ESCALATE EXPANDABLE PLATESTRYKER SPINE-FRANCE2017-05-15
TIMESHWARSAW ORTHOPEDICS2017-01-18
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2017-01-13
CENTERPIECE SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK2016-12-19
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2016-06-10
CENTERPIECE? PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2016-06-08
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2016-02-29
CENTERPIECE PLATE FIXATION SYSTEMMEDTRONIC SOFAMOR DANEK2016-02-19
MOUNTAINEER 3.5 DIAMETER SCREWDEPUY SYNTHES SPINE2016-02-05
NEWBRIDGE LFSORTHOFIX INC2016-01-19
ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METALMEDTRONIC SOFAMOR DANEK2015-11-30
CENTERPIECE PLATE FIXATION SYSTEMMEDTRONIC SOFAMOR DANEK2015-11-20
CENTERPIECE PLATE FIXATION SYSTEMMEDTRONIC SOFAMOR DANEK2015-10-07
LAMINOPLASTY FIXATION SYSTEMNUVASIVE, INC.2015-09-22
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2015-06-24
ORTHOSIS, SPINE, PLATE, LAMINOPLASTY METALSYNTHES USA2015-06-19
ORTHOSIS, SPINE, PLATE, LAMINOPLASTY METALSYNTHES USA2015-06-19
ORTHOSIS, SPINE, PLATE, LAMINOPLASTY METALSYNTHES USA2015-06-19
CENTERPIECE PLATE FIXATION SYSTEMWARSAW ORTHOPEDICS2015-06-09
ESCALATE EXPANDABLE PLATESTRYKER SPINE-FRANCE2015-05-29
CENTERPIECE? PLATE FIXATION SYSTEMWARSAW ORTHOPEDIC, INC.2015-04-16
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.