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

K212540Explorer TO SystemSeaSpine Orthopedics Corporation
K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.
K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody SystemAlphatec Spine, Inc.
K211740DualXAmplify Surgical, Inc.
K211413BEE PLIF CageNGMedical GmbH
K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4WEB Medical, Inc.
K211306LABYRINTHZavation Medical Products LLC
K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody SysMedtronic Sofamor Danek USA, Inc.
K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC
K210728CONDUIT InstrumentsMedos International, SARL
K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation
K210542Aprevo Transforaminal IBFCarlsmed, Inc.
K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu A•POD-L NanoMetalene, SeaSpine Vu E•POD System, SeaSpine Vu A•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine CSeaSpine Orthopedics Corporation
K210439NuVasive MOD-EX XLIF Interbody SystemNuVasive, Incorporated
K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek, USA 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

T-HANDLE INSERTEREIT EMERGING IMPLANT TECHNOLOGIES GMBH2020-03-31
INSERTEREIT EMERGING IMPLANT TECHNOLOGIES GMBH2020-03-31
CRESCENT SPINAL SYSTEMMSD DEGGENDORF MFG2020-03-27
PIVOX OBLIQUE LATERAL SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2020-03-27
PIVOX OBLIQUE LATERAL SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2020-03-27
NUVASIVE MLX MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM; NUVASIVE APNUVASIVE, INCORPORATED2020-03-26
NUVASIVE XLX INTERBODY SYSTEMNUVASIVE, INCORPORATED2020-03-26
NUVASIVE XLX INTERBODY SYSTEMNUVASIVE, INC2020-03-26
4WEB POSTERIOR SPINE TRUSS SYSTEM4WEB, INC.2020-03-26
CRESCENT SPINAL SYSTEMMSD DEGGENDORF MFG2020-03-26
NUVASIVE XLX INTERBODY SYSTEMNUVASIVE, INC2020-03-25
NUVASIVE MLX ? MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM; NUVASIVE APNUVASIVE, INCORPORATED2020-03-24
NUVASIVE MLX ? MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM; NUVASIVE APNUVASIVE, INCORPORATED2020-03-23
NUVASIVE MLX ? MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM; NUVASIVE APNUVASIVE, INCORPORATED2020-03-23
NUVASIVE MLX ? MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM; NUVASIVE APNUVASIVE, INCORPORATED2020-03-23
NUVASIVE MLX ? MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM; NUVASIVE APNUVASIVE, INCORPORATED2020-03-23
ELEVATE SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-23
PIVOX OBLIQUE LATERAL SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2020-03-22
ELEVATE SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2020-03-21
ELEVATE SPINAL SYSTEMWARSAW ORTHOPEDICS2020-03-20
NUVASIVE MODULUS XLIF INTERBODY SYSTEMNUVASIVE, INCORPORATED2020-03-20
NUVASIVE MLX MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEMNUVASIVE, INCORPORATED2020-03-20
ELEVATE SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2020-03-20
T-PAL SPACER APPLICATOR INNER SHAFTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-19
T-PAL ADVANCED APPLICATOR INNER SHAFTOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-19
T-PAL SPACER APPLICATOR KNOBOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-19
T-PAL ADVANCED APPLICATOR HANDLEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-19
NUVASIVE MLX ? MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM NUVASIVE APNUVASIVE, INCORPORATED2020-03-18
JULIET INSTRUMENTATIONSPINEART USA INC2020-03-18
IMPLANT INSERTER SH CONNECTIONEIT EMERGING IMPLANT TECHNOLOGIES GMBH2020-03-18
TRIAL INSERTER SH CONNECTIONEIT EMERGING IMPLANT TECHNOLOGIES GMBH2020-03-18
NUVASIVE MLX MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM NUVASIVE APNUVASIVE, INCORPORATED2020-03-17
T-HANDLE INSERTEREIT EMERGING IMPLANT TECHNOLOGIES GMBH2020-03-17
NUVASIVE MLX MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEMNUVASIVE, INC2020-03-17
NUVASIVE MLX MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEMNUVASIVE INC.2020-03-17
REFERENCE FRAMEMEDTRONIC NAVIGATION, INC2020-03-16
CROSS PIN FRAMEMEDTRONIC NAVIGATION, INC2020-03-16
AVS TL SPACER 9 X 30 X 4 DEGSTRYKER SPINE-US2020-03-13
ROI-A WIDE IMPLANT PXL : 27X36 H 12MM 14?LDR MEDICAL2020-03-13
ROI-A ANCHORING PLATE MLDR MEDICAL2020-03-13
NUVASIVE COROENT SYSTEMNUVASIVE INC.2020-03-12
VARILIFT LXWENZEL SPINE, INC.2020-03-12
VARILIFT LXWENZEL SPINE, INC.2020-03-12
VARILIFT LXWENZEL SPINE, INC.2020-03-12
VARILIFT LXWENZEL SPINE, INC.2020-03-12
4WEB ANTERIOR TRUSS SYSTEM4WEB, INC.2020-03-10
CLYDESDALE SPINAL SYSTEMMSD DEGGENDORF MFG2020-03-10
CONCORDE LIFT, CONVEX 9X21MEDOS INTERNATIONAL SàRL CH2020-03-09
PIVOX OBLIQUE LATERAL SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2020-03-08
PIVOX OBLIQUE LATERAL SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC2020-03-08

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