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The METICULY Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
METICULY COMPANY LIMITED
MF-313
In Commercial Distribution
- 18859751213134 ()
- 08859751213137 ()
- Craniofacial fixation plate, non-bioabsorbable, non-customized
The METICULY Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
METICULY COMPANY LIMITED
MF-312
In Commercial Distribution
- 18859751213127 ()
- 08859751213120 ()
- Craniofacial fixation plate, non-bioabsorbable, non-customized
The METICULY Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
METICULY COMPANY LIMITED
MF-311
In Commercial Distribution
- 18859751213110 ()
- 08859751213113 ()
- Craniofacial fixation plate, non-bioabsorbable, non-customized
The METICULY Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
METICULY COMPANY LIMITED
MF-314
In Commercial Distribution
- 18859751213141 ()
- 08859751213144 ()
- Craniofacial fixation plate, non-bioabsorbable, non-customized
DELTA 2.2MM PANEL 55X55X1.4MM
Stryker Leibinger GmbH & Co. KG
70-06355
In Commercial Distribution
- 04546540337344 ()
- Thickness: 1.4 Millimeter
- Width: 55.0 Millimeter
- Length: 55.0 Millimeter
70-06355
- Craniofacial fixation plate, bioabsorbable
DELTA 2.2MM MESH 55X55X1.4MM
Stryker Leibinger GmbH & Co. KG
70-06350
In Commercial Distribution
- 04546540337337 ()
- Thickness: 1.4 Millimeter
- Width: 55.0 Millimeter
- Length: 55.0 Millimeter
70-06350
- Craniofacial fixation plate, bioabsorbable
DELTA 2.2MM L-PLATE L-S 110 L, 9 HOLE
Stryker Leibinger GmbH & Co. KG
70-06141
In Commercial Distribution
- 04546540337276 ()
- Angle: 110.0 degree
- Number of Screw Holes: 9.0 Holes
70-06141
- Craniofacial fixation plate, bioabsorbable
DELTA 2.2MM STRAIGHT PLATE + BAR 4 HOLE
Stryker Leibinger GmbH & Co. KG
70-06104
In Commercial Distribution
- 04546540337221 ()
- Number of Screw Holes: 4.0 Holes
70-06104
- Craniofacial fixation plate, bioabsorbable
DELTA 1.7MM MESH 55X55X0.75MM
Stryker Leibinger GmbH & Co. KG
70-05345
In Commercial Distribution
- 04546540337207 ()
- Thickness: 0.75 Millimeter
- Width: 55.0 Millimeter
- Length: 55.0 Millimeter
70-05345
- Craniofacial fixation plate, bioabsorbable
DELTA 1.7MM BOX PLATE 2X2 HOLE
Stryker Leibinger GmbH & Co. KG
70-05310
In Commercial Distribution
- 04546540337184 ()
- 3D Plates: 2x2 Holes
70-05310
- Craniofacial fixation plate, bioabsorbable