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 šŸ”Ž
Intervertebral Fusion Device With Bone Graft, Lumbar [37411]21 CFR §888.3080 šŸ”Ž
Intervertebral Fusion Device With Bone Graft, Lumbar [38350]21 CFR §888.3080 šŸ”Ž
Intervertebral Fusion Device With Bone Graft, Lumbar [37409]21 CFR §888.3080 šŸ”Ž
Intervertebral Fusion Device With Bone Graft, Lumbar [37828]21 CFR §888.3080 šŸ”Ž
Intervertebral Fusion Device With Bone Graft, Lumbar [38349]21 CFR §888.3080 šŸ”Ž

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

K223065AdcuraĀ® SagittaeĀ® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.
K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc
K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.
K222082AprevoĀ® Anterior And Lateral Lumbar Interbody Fusion Devices, AprevoĀ® Transforaminal Lumbar Interbody Fusion DevicesCarlsmed, Inc.
K222028IdentiTiā„¢ Porous Ti Interbody System, IdentiTiā„¢ NanoTecā„¢ Interbody System, Transcendā„¢ PEEK Interbody System, Transcendā„¢ NanoTecā„¢ Interbody System, IdentiTiā„¢ ALIF Standalone Interbody System, IdentiTiā„¢ NanoTecā„¢ ALIF Standalone Interbody SystemAlphatec Spine
K221858ZSFab Lumbar Interbody SystemZS Fab Inc.
K221844TDM Lumbar Interbody Fusion Cage SystemTDM Co., Ltd
K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.
K221687Pegasus-X Expandable PLIF SystemGS Medical Co. Ltd.
K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC
K221325CONDUIT Lateral Switch PlateMedos International, SARL
K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty) Ltd
K221172FOCUS Interbody SystemOC Medical Devices
K220902Navagio Lumbar CageKalitec Medical, LLC
K220782IdentiTiā„¢ Porous Ti Interbody System, IdentiTiā„¢ NanoTecā„¢ Interbody System, Transcendā„¢ PEEK Interbody System, Transcendā„¢ NanoTecā„¢ Interbody System, IdentiTiā„¢ ALIF Standalone Interbody System, IdentiTiā„¢ NanoTecā„¢ ALIF Standalone Interbody System, IdentiAlphatec Spine, 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 SĆ RL 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

Ā© 2023 FDA.report
This site is not affiliated with or endorsed by the FDA.