Product Code: NKB


Products Classified as NKB

4644Thoracolumbosacral Pedicle Screw SystemThoracolumbosacral Pedicle Screw System.

Total Product Life Cycle (TPLC) Devices

4644Thoracolumbosacral Pedicle Screw SystemThoracolumbosacral Pedicle Screw System.

FDA Consensus Standards

Thoracolumbosacral Pedicle Screw System [37410]21 CFR §888.3070 🔎
Thoracolumbosacral Pedicle Screw System [37411]21 CFR §888.3070 🔎
Thoracolumbosacral Pedicle Screw System [35610]21 CFR §888.3070 🔎
Thoracolumbosacral Pedicle Screw System [37829]21 CFR §888.3070 🔎
Thoracolumbosacral Pedicle Screw System [37437]21 CFR §888.3070 🔎
Thoracolumbosacral Pedicle Screw System [38313]21 CFR §888.3070 🔎
Thoracolumbosacral Pedicle Screw System [38312]21 CFR §888.3070 🔎
Thoracolumbosacral Pedicle Screw System [37861]21 CFR §888.3070 🔎
Thoracolumbosacral Pedicle Screw System [37390]21 CFR §888.3070 🔎
Thoracolumbosacral Pedicle Screw System [34069]21 CFR §888.3070 🔎

Pre-market Notifications for NKB

K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics Ltd.
K201780True Tulip System, True M.I.S. SystemInnovative Surgical Designs, Inc.
K201751Pedicle Screw SystemBlack Box Medical LLC
K201648Sterispine™ PSSafe Orthopaedics
K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, INC.
K200666Stryker Xia 3 Power AdaptorStryker Spine
K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation
K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC
K200303Reform Pedicle Screw SystemPrecision Spine
K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.
K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl
K200070ARx Spinal SystemLife Spine Inc.
K193472OrthoCircle Spine Pedicle Screw SystemOrthoCircle Spine
K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC
K193423VADER®one Pedicle System MIS And LightMore® Pedicle System 6.0Icotec AG

Global Unique Device Identification Database

00613994950994Orthosis, spinal pedicle fixation, for degenerative disc disease
00613994950987Orthosis, spinal pedicle fixation, for degenerative disc disease
00613994950932Orthosis, spinal pedicle fixation, for degenerative disc disease
00613994950895Orthosis, spinal pedicle fixation, for degenerative disc disease
00613994950772Orthosis, spinal pedicle fixation, for degenerative disc disease
00613994950765Orthosis, spinal pedicle fixation, for degenerative disc disease
00613994950727Orthosis, spinal pedicle fixation, for degenerative disc disease
00613994950703Orthosis, spinal pedicle fixation, for degenerative disc disease
00613994950611Orthosis, spinal pedicle fixation, for degenerative disc disease
00613994950550Orthosis, spinal pedicle fixation, for degenerative disc disease
00613994950451Orthosis, spinal pedicle fixation, for degenerative disc disease
00613994950444Orthosis, spinal pedicle fixation, for degenerative disc disease
00613994950383Orthosis, spinal pedicle fixation, for degenerative disc disease
00613994950376Orthosis, spinal pedicle fixation, for degenerative disc disease
00613994950277Orthosis, spinal pedicle fixation, for degenerative disc disease

Maude Adverse Events

XIA TITANIUM 4.5 BLOCKERSTRYKER SPINE-US2020-03-31
XIA TITANIUM 4.5 BLOCKERSTRYKER SPINE-US2020-03-31
XIA TITANIUM 4.5 BLOCKERSTRYKER SPINE-US2020-03-31
XIA TITANIUM 4.5 BLOCKERSTRYKER SPINE-US2020-03-31
CD HORIZON SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC.2020-03-31
CD HORIZON SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC.2020-03-31
XIA 3 TITANIUM ROD DIAM 6MM TI ALLOY L 600MMSTRYKER SPINE-US2020-03-30
UNKNOWN CAGE/SPACERDEPUY SPINE INC2020-03-30
UNKNOWN CAGE/SPACERDEPUY SPINE INC2020-03-30
UNKNOWN CAGE/SPACERDEPUY SPINE INC2020-03-30
XIA 3 TITANIUM ROD DIAM 6MM TI ALLOY L 600MMSTRYKER SPINE-US2020-03-30
VITALITY?BIOMET SPINE LLC2020-03-30
CD HORIZON SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2020-03-29
CD HORIZON SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-28
CD HORIZON SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-28
CD HORIZON SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-28
CD HORIZON SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-28
CD HORIZON SOLERA SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-28
CD HORIZON SOLERA SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-28
CD HORIZON SOLERA VOYAGER SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-28
THORACOLUMBOSACRAL PEDICAL SCREW SYSTEMNUVASIVE, INCORPORATED2020-03-27
ASTRA SPINE SYSTEMSPINECRAFT2020-03-26
CD HORIZON SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-26
PRE-LORDOSED ROD W/LINE 95MMMEDOS INTERNATIONAL SàRL CH2020-03-26
PRE-LORDOSED ROD W/LINE 85MMMEDOS INTERNATIONAL SàRL CH2020-03-26
5.5 EXP VERSE UNITIZED SET SCRMEDOS INTERNATIONAL SàRL CH2020-03-26
5.5 EXP VERSE FEN SCR 7.0X40MEDOS INTERNATIONAL SàRL CH2020-03-26
EXPEDIUM SPINE SYSTEMMEDOS INTERNATIONAL SàRL CH2020-03-26
EXPEDIUM SPINE SYSTEMMEDOS INTERNATIONAL SàRL CH2020-03-26
EXPEDIUM SPINE SYSTEMMEDOS INTERNATIONAL SàRL CH2020-03-26
EXPEDIUM SPINE SYSTEMMEDOS INTERNATIONAL SàRL CH2020-03-26
EXP 635 TI SI SETSCREWMEDOS INTERNATIONAL SàRL CH2020-03-26
EXP 635 TI SI SETSCREWMEDOS INTERNATIONAL SàRL CH2020-03-26
CD HORIZON BALLAST SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2020-03-26
EXPEDIUM? VERSE SPINE SYSTEMMEDOS INTERNATIONAL SàRL CH2020-03-25
EXPEDIUM? VERSE SPINE SYSTEMMEDOS INTERNATIONAL SàRL CH2020-03-25
EXPEDIUM AND VIPER 2 SPINE SYSTEMDEPUY SPINE INC2020-03-25
EXPEDIUM AND VIPER 2 SPINE SYSTEMDEPUY SPINE INC2020-03-25
CD HORIZON SOLERA SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-25
SEQUOIA OPEN CLOSURE, 5.5M, TOP TIZIMMER BIOMET SPINE INC.2020-03-24
SEQUOIA OPEN CLOSURE, 5.5M, TOP TIZIMMER BIOMET SPINE INC.2020-03-24
SEQUOIA OPEN CLOSURE, 5.5M, TOP TIZIMMER BIOMET SPINE INC.2020-03-24
EASY SPINE ROD, UNKNOWNLDR MEDICAL2020-03-24
EASY SPINE ROD, UNKNOWNLDR MEDICAL2020-03-24
EASY SPINE SCREW, UNKNOWNLDR MEDICAL2020-03-24
NUVASIVE RELINE SYSTEMNUVASIVE, INCORPORATED2020-03-24
EASY SPINE SCREW, UNKNOWNLDR MEDICAL2020-03-24
EASY SPINE SCREW, UNKNOWNLDR MEDICAL2020-03-24
EASY SPINE SCREW, UNKNOWNLDR MEDICAL2020-03-24
ARSENAL SPINAL FIXATION SYSTEMALPHATEC SPINE INC.2020-03-24

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.