Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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4.25mm dia.12mm long variable screw Implant. The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PCP-425-12V
In Commercial Distribution

  • 90810005669170 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 12 Millimeter


  • Intervertebral-body internal spinal fixation system
3.75mm dia.14mm long variable screw Implant. The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PCP-375-14V
In Commercial Distribution

  • 90810005669125 ()

  • Outer Diameter: 3.75 Millimeter
  • Length: 14 Millimeter


  • Intervertebral-body internal spinal fixation system
4.25mm dia.14mm long fixed screw Implant. The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PCP-425-14F
In Commercial Distribution

  • 90810005669064 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 14 Millimeter


  • Intervertebral-body internal spinal fixation system
4.25mm dia.12mm long fixed screw Implant. The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PCP-425-12F
In Commercial Distribution

  • 90810005669057 ()

  • Outer Diameter: 4.25 Millimeter
  • Length: 12 Millimeter


  • Intervertebral-body internal spinal fixation system
Compaction Base
SpineArt SA
PAD-IN 04 00-N
In Commercial Distribution

  • 07640139349293 ()
PAD-IN 04 00-N

  • Bone graft packing block
Compactor
SpineArt SA
PAD-IN 05 00-N
In Commercial Distribution

  • 07640139349309 ()
PAD-IN 05 00-N

  • Bone graft packing block
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
TA2-006000
In Commercial Distribution

  • 10889981213022 ()
TA2-006000

  • Bone graft packing block
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
TO2-006000
In Commercial Distribution

  • 10889981195755 ()
TO2-006000

  • Bone graft packing block
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
36-90-3061
In Commercial Distribution

  • 10889981162368 ()
36-90-3061

  • Bone graft packing block
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Remote Control
In Commercial Distribution

  • 07290114064033 ()
700-006011-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Renishaw Non-XY frame Mechanical Set KIT
In Commercial Distribution

  • 27290114064044 ()
700-020050-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Ruler
In Commercial Distribution

  • 07290114061322 ()
215-001111-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Ruler and DBs holder thumb screw
In Commercial Distribution

  • 07290114061414 ()
344-001110-00

  • Depth electrode
SABER LUMBAR I/F CAGE SYSTEM BONE PACKING STAND
DEPUY SPINE, LLC
287006000
Not in Commercial Distribution

  • 10705034215716 ()
287006000

  • Bone graft packing block
Bone Packing Mold Base
K2M, INC.
1708-90043
In Commercial Distribution

  • 10888857023581 ()
1708-90043

  • Bone graft packing block
Bone Packing Mold, Size 12x17 mm
K2M, INC.
1708-90033
In Commercial Distribution

  • 10888857023529 ()
1708-90033

  • Bone graft packing block
Bone Packing Mold, Size 12x14 mm
K2M, INC.
1708-90032
In Commercial Distribution

  • 10888857023512 ()
1708-90032

  • Bone graft packing block
Compaction base
SpineArt SA
SCA-IC 04 00-N
In Commercial Distribution

  • 07640151086435 ()
SCA-IC 04 00-N

  • Bone graft packing block
COMPACTOR
SpineArt SA
SCA-IN 19 00-N
In Commercial Distribution

  • 07640185340862 ()
SCA-IN 19 00-N

  • Bone graft packing block
COMPACTION BASE
SpineArt SA
SCA-IN 07 00-N
In Commercial Distribution

  • 07640185340015 ()
SCA-IN 07 00-N

  • Bone graft packing block
Bone Condenser 8/9
BLUE SKY BIO LLC
STPCND89
In Commercial Distribution

  • 00810060223123 ()


  • Bone graft packing block
Bone Condenser 6/7
BLUE SKY BIO LLC
STPCND67
In Commercial Distribution

  • 00810060223109 ()


  • Bone graft packing block
Bone Condenser 4/5
BLUE SKY BIO LLC
STPCND45
In Commercial Distribution

  • 00810060223093 ()


  • Bone graft packing block
Bone Condenser 2/3
BLUE SKY BIO LLC
STPCND23
In Commercial Distribution

  • 00810060223086 ()


  • Bone graft packing block
Bone Condenser 10/11
BLUE SKY BIO LLC
STPCND1011
In Commercial Distribution

  • 00810060223079 ()


  • Bone graft packing block
SYNFIX® EVOLUTION IMPLANT PACKING STATION
Synthes GmbH
03.835.050
In Commercial Distribution

  • 07611819658172 ()
  • H981038350500 ()
  • 10705034814193 ()
03835050

  • Bone graft packing block
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Screwdriver
In Commercial Distribution

  • 07290114061308 ()
365-000015-00

  • Depth electrode
Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-4157
In Commercial Distribution

  • 10889981089917 ()
93-4157

  • Bone graft packing block
Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-3157
In Commercial Distribution

  • 10889981088309 ()
93-3157

  • Bone graft packing block
Pacifica-S Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-3156
In Commercial Distribution

  • 10889981088293 ()
93-3156

  • Bone graft packing block
Pacifica Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-3155
In Commercial Distribution

  • 10889981088286 ()
93-3155

  • Bone graft packing block
Graft Packing Block 30mm x 24mm x XXmm
SEASPINE ORTHOPEDICS CORPORATION
93-6116
In Commercial Distribution

  • 10889981091392 ()

  • 30mm x 24mm x XXmm
93-6116

  • Bone graft packing block
Graft Packing Block, 26mm
SEASPINE ORTHOPEDICS CORPORATION
93-6115
In Commercial Distribution

  • 10889981091385 ()

  • 26mm
93-6115

  • Bone graft packing block
Implant Assembly/Packing block
SEASPINE ORTHOPEDICS CORPORATION
86-0070
In Commercial Distribution

  • 10889981127121 ()
86-0070

  • Bone graft packing block
Packing Block
SEASPINE ORTHOPEDICS CORPORATION
86-0072
In Commercial Distribution

  • 10889981143336 ()
86-0072

  • Bone graft packing block
Extractor Block
SEASPINE ORTHOPEDICS CORPORATION
92-0126
In Commercial Distribution

  • 10889981086763 ()
92-0126

  • Bone graft packing block
VENTURA NM GRAFT PACKER
SEASPINE ORTHOPEDICS CORPORATION
SR-0229
In Commercial Distribution

  • 10889981157609 ()
SR-0229

  • Bone graft packing block
Shoreline/Admiral Graft Packer
SEASPINE ORTHOPEDICS CORPORATION
SR-0755
In Commercial Distribution

  • 10889981285364 ()
SR-0755

  • Bone graft packing block
Rotation Block
SEASPINE ORTHOPEDICS CORPORATION
25-40-0330
In Commercial Distribution

  • 10889981114800 ()
25-40-0330

  • Bone graft packing block
Screw Sizing Block
SEASPINE ORTHOPEDICS CORPORATION
25-40-0165
In Commercial Distribution

  • 10889981114640 ()
25-40-0165

  • Bone graft packing block
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061142 ()
700-021508-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Starfix frame Mechanical Set KIT
In Commercial Distribution

  • 27290014954100 ()
700-021508-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 17290114061770 ()
  • 07290114061773 ()
STR-000080-00

  • Depth electrode
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-36-0004
In Commercial Distribution

  • 09348215039905 ()


  • Instrument tray, reusable
No Description
Jeil Medical Corporation
111-299
In Commercial Distribution

  • 08806390885331 ()


  • Bone graft packing block
GRAFT PACKING BLOCK-MEDIUM FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.073
In Commercial Distribution

  • 07611819534773 ()
  • H981038250730 ()
  • 10705034732046 ()
03825073

  • Bone graft packing block
GRAFT PACKING BLOCK-SMALL FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.072
In Commercial Distribution

  • 07611819534766 ()
  • H981038250720 ()
  • 10705034732039 ()
03825072

  • Bone graft packing block
GRAFT PACKING BLOCK-LARGE FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.074
In Commercial Distribution

  • 07611819534780 ()
  • H981038250740 ()
  • 10705034732053 ()
03825074

  • Bone graft packing block
PACKING BLOCK FOR 30MM DEPTH/ 38MM WIDTH SYNFIX(TM)-LR
SYNTHES (U.S.A.) LP
03.802.042
Not in Commercial Distribution

  • 07611819297425 ()
  • H981038020420 ()
  • 10705034722276 ()
03802042

  • Bone graft packing block
PACKING BLOCK FOR 26MM DEPTH/ 32MM WIDTH SYNFIX(TM)-LR
SYNTHES (U.S.A.) LP
03.802.041
Not in Commercial Distribution

  • 07611819791268 ()
  • H981038020410 ()
  • 10705034722269 ()
03802041

  • Bone graft packing block
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