Product Code: MAX


Products Classified as MAX

4612Intervertebral Fusion Device With Bone Graft, LumbarIntervertebral Body Fusion Device.

Total Product Life Cycle (TPLC) Devices

4612Intervertebral Fusion Device With Bone Graft, LumbarIntervertebral Body Fusion Device.

FDA Consensus Standards

Intervertebral Fusion Device With Bone Graft, Lumbar [37410]21 CFR §888.3080 🔎
Intervertebral Fusion Device With Bone Graft, Lumbar [37411]21 CFR §888.3080 🔎
Intervertebral Fusion Device With Bone Graft, Lumbar [38350]21 CFR §888.3080 🔎
Intervertebral Fusion Device With Bone Graft, Lumbar [37409]21 CFR §888.3080 🔎
Intervertebral Fusion Device With Bone Graft, Lumbar [37828]21 CFR §888.3080 🔎
Intervertebral Fusion Device With Bone Graft, Lumbar [38349]21 CFR §888.3080 🔎

Pre-market Approvals for MAX

P960025BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWSDEPUY SPINE,INC
P950019RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATIONSTRYKER SPINE
P970015INTER FIX RP THREADED FUSION DEVICE-REDUCED PROFILESOFAMOR DANEK

Pre-market Notifications for MAX

K193645Nva, Nvp, And NvtNvision Biomedical Technologies, Inc.
K193521Steerable Plateau TiLife Spine, Inc.
K193370Nexxt Matrixx SystemNexxt Spine LLC
K193255Largo PEEK Interbody SystemFloSpine, LLC
K193203MOJAVE Expandable Interbody SystemK2M, Inc.
K193174Keos Lumbar IBFDKeos
K192760NuVasive Modulus XLIF Interbody SystemNuVasive, Incorporated
K192718Fortilink Interbody Fusion Device (IBF) With TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., DBA RTI Surgical, Inc.
K192687TrellOss™-L MPFNexxt Spine LLC
K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ SMedtronic Sofamor Danek USA, Inc
K192497EVOL Ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC
K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical Inc
K192248Cortina™ [MAX] Lumbar Cage SystemNeuroStructures, Inc.
K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation
K192115SABLE Expandable SpacerGlobus Medical Inc.

Global Unique Device Identification Database

00366313603124Intervertebral Fusion Device With Bone Graft, Lumbar
00613994916341Intervertebral fusion device with bone graft, lumbar
00613994916334Intervertebral fusion device with bone graft, lumbar
00613994916327Intervertebral fusion device with bone graft, lumbar
00613994916310Intervertebral fusion device with bone graft, lumbar
00613994916303Intervertebral fusion device with bone graft, lumbar
00613994916297Intervertebral fusion device with bone graft, lumbar
00613994916280Intervertebral fusion device with bone graft, lumbar
00613994916273Intervertebral fusion device with bone graft, lumbar
00613994916266Intervertebral fusion device with bone graft, lumbar
00613994916259Intervertebral fusion device with bone graft, lumbar
00613994916242Intervertebral fusion device with bone graft, lumbar
00613994916235Intervertebral fusion device with bone graft, lumbar
00613994916228Intervertebral fusion device with bone graft, lumbar
00613994916211Intervertebral fusion device with bone graft, lumbar

Maude Adverse Events

CAPSTONE SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2019-11-29
SKIPJACK EXPANDABLE SYSTEMSEASPINE INC.2019-11-27
10MM, 06?, LUNA IMPLANT, PEEKBENVENUE MEDICAL, INC.2019-11-27
ELEVATE SPINAL SYSTEMWARSAW ORTHOPEDICS2019-11-27
CLYDESDALE PTC SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK2019-11-26
CRESCENT SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2019-11-25
UNKNOWN CONCORDE LIFT CAGEMEDOS INTERNATIONAL SàRL CH2019-11-25
CONCORDE BUL LOR 11X13X27, 5 DMEDOS INTERNATIONAL SàRL CH2019-11-25
UNK - CAGE/SPACERS: T-PALWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-22
T-PAL SPACER APPLICATOR INNER SHAFTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-22
NUVASIVE COROENT SYSTEMNUVASIVE2019-11-21
CLYDESDALE PTC SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2019-11-21
CLYDESDALE PTC SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2019-11-21
INNER SHAFT, STANDARD INSERTERZIMMER BIOMET SPINE INC.2019-11-20
OUTER SHAFT, STANDARD INSERTERZIMMER BIOMET SPINE INC.2019-11-20
UNK INSERTION INSTRUMENTS: EITEIT EMERGING IMPLANT TECHNOLOGIES GMBH2019-11-20
CLYDESDALE PTC SPINAL SYSTEMMSD DEGGENDORF MFG2019-11-19
ELEVATE SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2019-11-18
ORACLE CAGE 50*22 H13 8? PEEKOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-18
UNKNOWN CAGE/SPACERMEDOS INTERNATIONAL SàRL CH2019-11-15
CURVE VARIABLE INSERTER SHAFTZIMMER BIOMET SPINE INC.2019-11-15
CURVE VARIABLE INSERTER SHAFTZIMMER BIOMET SPINE INC.2019-11-15
T-PAL SPACER APPLICATOR HANDLEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-15
T-PAL SPACER APPLICATOR KNOBWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-15
CLYDESDALE PTC SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2019-11-15
INNER SHAFT, STANDARD INSERTERZIMMER BIOMET SPINE INC.2019-11-15
CAPSTONE CONTROL PTC SPINAL SYSTEMMDT PUERTO RICO OPERATIONS CO, MED REL2019-11-15
OUTER SHAFT, STANDARD INSERTERZIMMER BIOMET SPINE INC.2019-11-14
CLYDESDALE SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2019-11-14
T-PAL SPACER APPLICATOR KNOBOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-13
APPLICATOR INNER SHAFTOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-13
T-HANDLE INSERTEREIT EMERGING IMPLANT TECHNOLOGIES GMBH2019-11-13
9MM X 6DEG X 9MM X 23MMSTRYKER SPINE-US2019-11-12
TM ARDIS® INTERBODY SYSTEM SOLIDZIMMER TMT2019-11-12
PIVOX OBLIQUE LATERAL SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2019-11-12
UNKNOWN CONCORDE LIFT CAGEMEDOS INTERNATIONAL SàRL CH2019-11-12
UNKNOWN CONCORDE LIFT CAGEMEDOS INTERNATIONAL SàRL CH2019-11-11
CLYDESDALE PTC SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2019-11-09
ROI-A ANCHORING PLATE MLDR MEDICAL2019-11-08
ROI-A WIDE IMPLANT PXL : 27X36 H 16MM 10?LDR MEDICAL2019-11-08
T-PAL ADVANCED APPLICATOR INNER SHAFTOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-07
T-PAL ADVANCED APPLICATOR HANDLEOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-07
T-PAL SPACER APPLICATOR KNOB --------------------------OBERDORF SYNTHES PRODUKTIONS GMBH2019-11-07
PIVOX? OBLIQUE LATERAL SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2019-11-05
PIVOX? OBLIQUE LATERAL SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2019-11-04
T-PAL SPACER APPLICATOR INNER SHAFTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-04
T-PAL SPACER APPLICATOR KNOBWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-04
PIVOX OBLIQUE LATERAL SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2019-11-04
CRESCENT SPINAL SYSTEMMSD DEGGENDORF MFG2019-11-02
CRESCENT SPINAL SYSTEMMSD DEGGENDORF MFG2019-11-02

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