Product Code: NKG


Products Classified as NKG

4736Orthosis, Cervical Pedicle Screw Spinal Fixation

Total Product Life Cycle (TPLC) Devices

4736Orthosis, Cervical Pedicle Screw Spinal Fixation

FDA Consensus Standards

Posterior Cervical Screw System [37829]21 CFR §888.3075 🔎
Posterior Cervical Screw System [37437]21 CFR §888.3075 🔎
Posterior Cervical Screw System [38313]21 CFR §888.3075 🔎
Posterior Cervical Screw System [38312]21 CFR §888.3075 🔎
Posterior Cervical Screw System [38330]21 CFR §888.3075 🔎
Posterior Cervical Screw System [38329]21 CFR §888.3075 🔎

Pre-market Notifications for NKG

K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic
K203319SYMPHONY™ OCT SystemMedos International Sarl
K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International SA
K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.
K201481Centurion POCT SystemOrthofix Inc.
K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.
K200793LnK Posterior Cervical Fixation System And CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.
K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSPINEART
K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International SA
K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation
K193129Yukon OCT Spinal SystemK2M, Inc.
K192646SYMPHONY™ OCT SystemMedos International SARL
K192354Innovasis Gibralt Spine SystemInnovasis, Inc.
K192013VERTICALE® Cervical SystemSilony Medical GmbH
K192014SYPMHONY™ OCT SystemMedos International SARL

Global Unique Device Identification Database

00613994641915Orthosis, cervical pedicle screw spinal fixation
00643169101463Orthosis, cervical pedicle screw spinal fixation
00643169101371Orthosis, cervical pedicle screw spinal fixation
00643169101333Orthosis, cervical pedicle screw spinal fixation
00643169839656Orthosis, cervical pedicle screw spinal fixation
00643169839625Orthosis, cervical pedicle screw spinal fixation
00643169839618Orthosis, cervical pedicle screw spinal fixation
00643169839601Orthosis, cervical pedicle screw spinal fixation
00643169839595Orthosis, cervical pedicle screw spinal fixation
00643169839588Orthosis, cervical pedicle screw spinal fixation
00643169839557Orthosis, cervical pedicle screw spinal fixation
00643169839526Orthosis, cervical pedicle screw spinal fixation
00643169839502Orthosis, cervical pedicle screw spinal fixation
00643169839465Orthosis, cervical pedicle screw spinal fixation
00643169839458Orthosis, cervical pedicle screw spinal fixation

Maude Adverse Events

MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 31MMMEDOS INTERNATIONAL SàRL CH2020-03-31
4.0MM TI CANCELLOUS POLYAXIAL SCREW 26MM FOR 4.0MM RODSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-30
POLYAXIAL SCREW; SIZE ?5.0X30 MMK2M, INC.2020-03-27
POLYAXIAL SCREW; SIZE ?5.0X30 MMK2M, INC.2020-03-27
TI LOCKING SCREW - STERILEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
TI LOCKING SCREW - STERILEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
4.0MM TI CANCELLOUS POLYAXIAL SCREW 26MM FOR 4.0MM RODOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
UNK - LOCKING/SET SCREWS: SYNAPSEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
UNK - LOCKING/SET SCREWS: SYNAPSEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
4.5MM TI CANCELLOUS POLYAXIAL SCREW 38MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
4.5MM TI CANCELLOUS POLYAXIAL SCREW 40MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
POLYAXIAL SCREW; SIZE ?5.0X30 MMK2M, INC.2020-03-24
POLYAXIAL SCREW; SIZE ?5.0X28 MMK2M, INC.2020-03-18
SET SCREWK2M, INC.2020-03-16
SET SCREWK2M, INC.2020-03-16
SET SCREWK2M, INC.2020-03-16
SET SCREWK2M, INC.2020-03-16
ANGLED TI TOP LOADING TRANSCONNECTOR/MEDIUMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-14
TI TOP LOADING TRANSCONNECTOR MEDIUMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-13
OCCIPITAL-PL 4.5/5 MED W/50 TIOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-12
CANCELLOUSSCR SYNAPSE ?3.5 L14 TANOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-12
POLYAXIAL SCREW; SIZE ?4.5X30 MMK2M, INC.2020-03-11
POLYAXIAL SCREW; SIZE ?4.5X30 MMK2M, INC.2020-03-11
3.5MM TI CANCELLOUS POLYAXIAL SCREW 14MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-11
4.0MM TI CANCELLOUS POLYAXIAL SCREW 50MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-10
OASYS BLOCKERSTRYKER SPINE-US2020-03-09
OASYS 3.5 X 28MM PA SCREW MEDIALSTRYKER SPINE-US2020-03-09
OASYS BLOCKERSTRYKER SPINE-US2020-03-09
POLYAXIAL SCREW; SIZE ?3.5X26 MMK2M, INC.2020-02-28
OASYS 3.5X26MM POLYAXIAL SCREWSTRYKER SPINE-US2020-02-26
PIONEER SURGICAL TECHNOLOGY, INC STREAMLINE OCT OCCIPTIO-CERVICO- THORACIC SYSTEPIONEER SURGICAL (D.B.A. RTI SURGICAL)2020-02-21
PROFICIENT POSTERIOR CERVICAL SPINE SYSTEMSPINE WAVE, INC.2020-02-19
UNKNOWN_SPINE_PRODUCTSTRYKER SPINE-US2020-02-12
UNKNOWN_SPINE_PRODUCTSTRYKER SPINE-US2020-02-12
UNKNOWN_SPINE_PRODUCTSTRYKER SPINE-US2020-02-10
UNKNOWN_SPINE_PRODUCTSTRYKER SPINE-US2020-02-10
UNKNOWN_SPINE_PRODUCTSTRYKER SPINE-US2020-02-10
UNKNOWN_SPINE_PRODUCTSTRYKER SPINE-US2020-02-10
TI TRANSCONNECTOR LOCKING SCREWWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-07
TI TRANSCONNECTOR LOCKING SCREWWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-07
TI TRANSCONNECTOR LOCKING SCREWWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-07
OASYS BLOCKERSTRYKER SPINE-US2020-02-06
OASYS BLOCKERSTRYKER SPINE-US2020-02-06
OASYS BLOCKERSTRYKER SPINE-US2020-02-06
OASYS BLOCKERSTRYKER SPINE-US2020-02-06
OASYS BLOCKERSTRYKER SPINE-US2020-02-06
3.5MM TI CANCELLOUS POLYAXIAL SCREW 16MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-05
3.5MM TI CANCELLOUS POLYAXIAL SCREW 16MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-05
3.5MM TI CANCELLOUS POLYAXIAL SCREW 16MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-05
OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 24STRYKER SPINE-US2020-02-01

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