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

K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.
K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA
K212185Golden Isles Pedicle Screw SystemIntelivation LLC
K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.
K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation
K211323ASTRA Spine SystemSpineCraft, LLC
K211113Zavation Spinal SystemZavation Medical Products LLC
K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC
K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics Ltd.
K210637CD Horizon™ Spinal SystemMedtronic
K210549ARx Spinal SystemLife Spine, Inc.
K210539CoreLink Midline Fixation SystemCoreLink, LLC
K210306GII Spinal Fixation SystemColigne AG
K210275Polaris Spinal SystemZimmer Biomet Spine, Inc
K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG

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

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