Intervertebral Fusion Device With Bone Graft, Lumbar
FDA product code MAX · 785 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3080
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2007-10-11 – 2026-08-20
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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2012-08-24
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2012-08-23
TRANS1 INTERBODY FUSION SYSTEM
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INFILL INTERVERTEBRAL BODY FUSION DEVICE
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2012-07-06
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
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2012-07-05
ACCULIF TL CAGE
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2012-07-03
DEPUY PULSE LUMBAR CAGE SYSTEM
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2012-06-29
WAVE D CAGE
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2012-06-29
LOOP CAGE
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2012-06-29
WAVE O CAGE
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2012-06-29
FUSE CAGE
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2012-06-28
NUVASIVE COROENT TITANIUM SYSTEM
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2012-06-15
MEDYSSY LT CAGE SYSTEM
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2012-06-15
TM-400 DEVICE
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2012-06-13
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
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2012-05-29
TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION
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2012-05-23
LUCENT OR LUCENT MAGNUM
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2012-05-08
PLATEAU SPACER SYSTEM
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2012-05-01
LATERAL FUSION DEVICE
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2012-04-19
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
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2012-04-18
TWIN PEAKS LUMBAR CAGE
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2012-04-09
CAPSTONE CONTROL SPINAL SYSTEM
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2012-03-28
ZAVATION IBF SYSTEM
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2012-03-13
ASFORA BULLET CAGE
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2012-03-12
RELIANCE LUMBAR IBF SYSTEM
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2012-03-05
PLIF CAGE
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MAX
2012-03-05
MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI
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MAX
2012-02-29
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE
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2012-02-28
MECTALIF TRANSFORAMINAL
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2012-02-06
PERIMETER INTERBODY FUSION DEVICE
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2012-02-06
PATHWAY AVID
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2012-01-26
RISE SPACER
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2012-01-26
SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE
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2012-01-20
OPTICAGE INTERBODY FUSION DEVICE
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2012-01-10
ALEUTIAN SYSTEM
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2011-12-20
CLYDESDALE(R) SPINAL SYSTEM
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2011-12-14
4-WEB ALIF SPINAL TRUSS SYSTEM (STS)
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MAX
2011-12-13
COUGAR SYSTEM
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MAX
2011-12-12
ACCULIF TL CAGE
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MAX
2011-12-01
ACCULIF TL-PEEK IBF CAGE
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MAX
2011-11-21
CLYDESDALES SPINAL SYSTEM
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2011-11-09
TELAMON PEEK SPINAL SYSTEM
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2011-11-08
PROW FUSION
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2011-10-26
BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM
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2011-10-25
VUSION(R) OS
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MAX
2011-10-24
VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
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2011-10-17
ZYSTON STRAIGHT SPACER SYSTEM
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2011-10-17
GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)
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2011-10-11
CONCORDE BULLET SPINAL SYSTEM
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MAX
2011-09-28
PIONEER CROSSFUSE II IBF/VBR SYSTEM
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MAX
2011-09-28
SPINEFRONTIER LUMBAR IBF SYSTEM
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MAX
2011-09-26
SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
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MAX
2011-09-13
MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
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MAX
2011-09-08
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
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2011-08-24
PERIMETER INTERBODY FUSION DEVICE
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MAX
2011-08-09
CRESCENT (R) SPINAL SYSTEM TITANIUM
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MAX
2011-07-21
ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER
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MAX
2011-07-20
PATHWAY MODEL 07XXXX
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2011-07-18
CAPSTONE R SPINAL SYSTEM
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2011-07-06
PLATEAU SPACER SYSTEM
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MAX
2011-06-30
ZYSTON ARC INTERBODY SPACER
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2011-06-22
ALEUTIAN SPACER SYSTEM
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MAX
2011-06-13
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
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MAX
2011-06-13
MECTALIF
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MAX
2011-05-27
INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
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MAX
2011-05-13
COUGAR LS LATERAL CAGE SYSTEM
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MAX
2011-05-12
SEASPINE SPACER SYSTEM
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MAX
2011-04-28
CUTTING EDGE SPINE INTERBODY FUSION DEVICE
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MAX
2011-04-21
HELENA SYSTEM
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MAX
2011-04-18
INFILL INTERVERTEBRAL BODY FUSION DEVICE
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2011-04-08
LP CAGE
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MAX
2011-04-07
ACCULIF CAGE
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MAX
2011-03-23
LANX LATERAL
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MAX
2011-03-23
FORZA SPACER SYSTEM
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MAX
2011-03-17
PEZO INTERBODY CAGES SYSTEM
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MAX
2011-03-17
CONCORDE CURVE SYSTEM
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MAX
2011-03-02
CONCORDE BULLET CAGE SYSTEM
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MAX
2011-02-09
FUSE PLIF CAFE
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MAX
2011-02-03
INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE
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MAX
2011-01-27
REDONDO-L
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MAX
2011-01-18
ALIF SPINAL TRUSS INTERBODY FUSION DEVICE
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MAX
2011-01-07
STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)
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2011-01-05
PARAMOUNT R IBF DEVICE
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2011-01-05
CALIBER SPACER
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2010-12-10
GENESYS SPINE INTERBODY FUSION SYSTEM
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2010-12-03
PATRIOT TRANSCONTINENTAL M SPACERS
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2010-12-01
CONCORDE CURVE SYSTEM
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2010-11-05
ENDOSKELETON TO
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MAX
2010-10-06
INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
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MAX
2010-10-01
DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM
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MAX
2010-09-24
STALIF MIDLINE
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2010-09-23
ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD
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2010-08-26
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2010-08-12
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2010-08-10
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2010-08-05
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2010-07-22
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2010-07-16
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