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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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The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844112397 ()

  • 12x10x20mm
TST06121020

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844112373 ()

  • 10x10x20mm
TST00101020

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844112359 ()

  • 8x10x20mm
TST00081020

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844112342 ()

  • 7x10x20mm
TST00071020

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844112328 ()

  • 11x10x20mm
TST00111020

  • Metallic spinal interbody fusion cage
The HistoCore SPECTRA ST is an in-vitro diagnostics instrument. The HistoCore SPECTRA ST is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.
Leica Biosystems Nussloch GmbH
000000014051254354
In Commercial Distribution

  • 04049188191953 ()

  • Device Size Text, specify:
14051254354

  • Microscope slide stainer IVD
Ø5/ L=15
Megagen Implant Co. Ltd
ST5015
In Commercial Distribution

  • 08806388236954 ()
ST5015C

  • Screw endosteal dental implant, two-piece
Ø5/ L=13
Megagen Implant Co. Ltd
ST5013
In Commercial Distribution

  • 08806388236947 ()
ST5013C

  • Screw endosteal dental implant, two-piece
Ø5/ L=11.5
Megagen Implant Co. Ltd
ST5011
In Commercial Distribution

  • 08806388236930 ()
ST5011C

  • Screw endosteal dental implant, two-piece
Ø5/ L=10
Megagen Implant Co. Ltd
ST5010
In Commercial Distribution

  • 08806388236923 ()
ST5010C

  • Screw endosteal dental implant, two-piece
Ø5/ L=8.5
Megagen Implant Co. Ltd
ST5008
In Commercial Distribution

  • 08806388236916 ()
ST5008C

  • Screw endosteal dental implant, two-piece
Ø5/ L=7
Megagen Implant Co. Ltd
ST5007
In Commercial Distribution

  • 08806388236909 ()
ST5007C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=15
Megagen Implant Co. Ltd
ST4515
In Commercial Distribution

  • 08806388236893 ()
ST4515C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=13
Megagen Implant Co. Ltd
ST4513
In Commercial Distribution

  • 08806388236886 ()
ST4513C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=11.5
Megagen Implant Co. Ltd
ST4511
In Commercial Distribution

  • 08806388236879 ()
ST4511C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=10
Megagen Implant Co. Ltd
ST4510
In Commercial Distribution

  • 08806388236862 ()
ST4510C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=8.5
Megagen Implant Co. Ltd
ST4508
In Commercial Distribution

  • 08806388236855 ()
ST4508C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=7
Megagen Implant Co. Ltd
ST4507
In Commercial Distribution

  • 08806388236848 ()
ST4507C

  • Screw endosteal dental implant, two-piece
Ø4/ L=15
Megagen Implant Co. Ltd
ST4015
In Commercial Distribution

  • 08806388236831 ()
ST4015C

  • Screw endosteal dental implant, two-piece
Ø4/ L=13
Megagen Implant Co. Ltd
ST4013
In Commercial Distribution

  • 08806388236824 ()
ST4013C

  • Screw endosteal dental implant, two-piece
Ø4/ L=11.5
Megagen Implant Co. Ltd
ST4011
In Commercial Distribution

  • 08806388236817 ()
ST4011C

  • Screw endosteal dental implant, two-piece
Ø4/ L=10
Megagen Implant Co. Ltd
ST4010
In Commercial Distribution

  • 08806388236800 ()
ST4010C

  • Screw endosteal dental implant, two-piece
Ø4/ L=8.5
Megagen Implant Co. Ltd
ST4008
In Commercial Distribution

  • 08806388236794 ()
ST4008C

  • Screw endosteal dental implant, two-piece
Ø4/ L=7
Megagen Implant Co. Ltd
ST4007
In Commercial Distribution

  • 08806388236787 ()
ST4007C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=15
Megagen Implant Co. Ltd
ST3515
In Commercial Distribution

  • 08806388236770 ()
ST3515C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=13
Megagen Implant Co. Ltd
ST3513
In Commercial Distribution

  • 08806388236763 ()
ST3513C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=11.5
Megagen Implant Co. Ltd
ST3511
In Commercial Distribution

  • 08806388236756 ()
ST3511C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=10
Megagen Implant Co. Ltd
ST3510
In Commercial Distribution

  • 08806388236749 ()
ST3510C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=8.5
Megagen Implant Co. Ltd
ST3508
In Commercial Distribution

  • 08806388236732 ()
ST3508C

  • Screw endosteal dental implant, two-piece
The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The St. Louis Band is made with an outer copolymer plastic shell and an inner liner made of Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding rivet mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
763.08PA
In Commercial Distribution

  • B15176308PA0 ()
763.08PA

  • Cranial orthosis
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