Product Code: KWP


Products Classified as KWP

4574Appliance, Fixation, Spinal InterlaminalSpinal Interlaminal Fixation Orthosis.

Total Product Life Cycle (TPLC) Devices

4574Appliance, Fixation, Spinal InterlaminalSpinal Interlaminal Fixation Orthosis.

FDA Consensus Standards

Appliance, Fixation, Spinal Interlaminal [37410]21 CFR §888.3050 🔎
Appliance, Fixation, Spinal Interlaminal [37411]21 CFR §888.3050 🔎
Appliance, Fixation, Spinal Interlaminal [37829]21 CFR §888.3050 🔎
Appliance, Fixation, Spinal Interlaminal [37437]21 CFR §888.3050 🔎
Appliance, Fixation, Spinal Interlaminal [38313]21 CFR §888.3050 🔎
Appliance, Fixation, Spinal Interlaminal [38312]21 CFR §888.3050 🔎
Appliance, Fixation, Spinal Interlaminal [32387]21 CFR §888.3050 🔎
Appliance, Fixation, Spinal Interlaminal [38330]21 CFR §888.3050 🔎
Appliance, Fixation, Spinal Interlaminal [38329]21 CFR §888.3050 🔎
Appliance, Fixation, Spinal Interlaminal [37808]21 CFR §888.3050 🔎

Pre-market Notifications for KWP

K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPRECISION SPINE, INC.
K150753OASYS SystemSTRYKER CORPORATION
K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
K150229SOLSTICE OCT SystemLIFE SPINE, INC
K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.
K143249SOLSTICE OCT SystemLIFE SPINE, INC
K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC
K142741OASYS SystemSTRYKER CORPORATION
K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2M
K142460EXPEDIUM Spine System/Synapse SystemJOHNSON AND JOHNSON
K142253SOLSTICE OCT SystemLIFE SPINE, INC
K141897SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEMSYNTHES USA PRODUCTS, LLC
K141284CASPIAN SPINAL SYSTEMK2M, INC.
K140734NEXTGEN ALTIUS OCT SYSTEMEBI, LLC
K140645GIBRALT ROD-TO-ROD CROSS CONNECTORSEXACTECH SARASOTA

Global Unique Device Identification Database

00613994953087APPLIANCE, FIXATION, SPINAL INTERLAMINAL
00613994953070APPLIANCE, FIXATION, SPINAL INTERLAMINAL
00613994950949APPLIANCE, FIXATION, SPINAL INTERLAMINAL
00613994950901APPLIANCE, FIXATION, SPINAL INTERLAMINAL
00613994950888APPLIANCE, FIXATION, SPINAL INTERLAMINAL
00613994950680APPLIANCE, FIXATION, SPINAL INTERLAMINAL
00613994950666APPLIANCE, FIXATION, SPINAL INTERLAMINAL
00613994950659APPLIANCE, FIXATION, SPINAL INTERLAMINAL
00613994950642APPLIANCE, FIXATION, SPINAL INTERLAMINAL
00613994950598APPLIANCE, FIXATION, SPINAL INTERLAMINAL
00613994950512APPLIANCE, FIXATION, SPINAL INTERLAMINAL
00613994950505APPLIANCE, FIXATION, SPINAL INTERLAMINAL
00613994950499APPLIANCE, FIXATION, SPINAL INTERLAMINAL
00613994950475APPLIANCE, FIXATION, SPINAL INTERLAMINAL
00613994950352APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Maude Adverse Events

CD HORIZON SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-31
CD HORIZON SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-31
NEON3ULRICH GMBH & CO. KG2020-03-30
NEON3ULRICH GMBH & CO. KG2020-03-30
NEON3ULRICH GMBH & CO. KG2020-03-30
NOEO3ULRICH GMBH & CO. KG2020-03-30
NEON3ULRICH GMBH & CO. KG2020-03-30
NEON3ULRICH GMBH & CO. KG2020-03-30
APPLIANCE, FIXATION, SPINAL INTERLAMINALMEDTRONIC SOFAMOR DANEK USA, INC.2020-03-30
CD HORIZON SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-27
CD HORIZON SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-27
CD HORIZON SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-27
INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-25
CD HORIZON SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-25
CD HORIZON SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-25
CD HORIZON SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC.2020-03-25
NEON3ULRICH GMBH & CO. KG2020-03-24
NEON3ULRICH GMBH & CO. KG2020-03-24
NEON3ULRICH GMBH & CO. KG2020-03-24
NEON3ULRICH GMBH & CO. KG2020-03-24
MEDTRONIC SOFAMOR DANEK USA, INC.2020-03-24
CD HORIZON SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-22
CD HORIZON SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-22
CD HORIZON SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-22
CD HORIZON SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-22
APPLIANCE, FIXATION, SPINAL INTERLAMINALMEDTRONIC SOFAMOR DANEK USA, INC.2020-03-22
CD HORIZON SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC.2020-03-22
RESPONSE 5.5/6.0 ROD REDUCER ASSEMBLYORTHOPEDIATRICS, INC2020-03-20
CD HORIZON SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-20
CD HORIZON SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-20
UNKNOWN_SPINE_PRODUCTSTRYKER SPINE-US2020-03-19
EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5MEDOS INTERNATIONAL SàRL CH2020-03-19
CD HORIZON SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-18
CD HORIZON SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-18
APPLIANCE, FIXATION, SPINAL INTERLAMINALMEDTRONIC SOFAMOR DANEK USA, INC.2020-03-17
APPLIANCE, FIXATION, SPINAL INTERLAMINALMEDTRONIC SOFAMOR DANEK USA, INC.2020-03-17
VERTEX RECONSTRUCTION SYSTEMWARSAW ORTHOPEDICS2020-03-17
VERTEX RECONSTRUCTION SYSTEMWARSAW ORTHOPEDICS2020-03-17
CD HORIZON SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC.2020-03-17
VIRAGE SCREW, UNKNOWNZIMMER BIOMET SPINE INC.2020-03-17
VIRAGE SCREW, UNKNOWNZIMMER BIOMET SPINE INC.2020-03-17
VIRAGE SCREW, UNKNOWNZIMMER BIOMET SPINE INC.2020-03-17
VIRAGE SCREW, UNKNOWNZIMMER BIOMET SPINE INC.2020-03-17
VIRAGE SCREW, UNKNOWNZIMMER BIOMET SPINE INC.2020-03-17
VIRAGE SCREW, UNKNOWNZIMMER BIOMET SPINE INC.2020-03-17
CD HORIZON SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC.2020-03-17
APPLIANCE, FIXATION, SPINAL INTERLAMINALMEDTRONIC SOFAMOR DANEK USA, INC.2020-03-17
CD HORIZON SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-13
CD HORIZON SOLERA SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-12
MEDACTA PEDICLE SCREWMEDACTA INTERNATIONAL SA2020-03-09
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