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 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-212
In Commercial Distribution

  • 18859751212120 ()
  • 08859751212123 ()


  • Orbital rim prosthesis
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-211
In Commercial Distribution

  • 18859751212113 ()
  • 08859751212116 ()


  • Orbital rim prosthesis
Double Nasal Hood Single Use, Pediatric, Scent Pure Ghost 12 Hoods individually wrapped in a box To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.
Baldus Sedation GmbH & Co. KG
NHP12PG
In Commercial Distribution

  • 04260635790608 ()


  • Anaesthesia face mask, single-use
Double Nasal Hood Single Use, Pediatric, Scent Happy Apple 12 Hoods individually wrapped in a box To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.
Baldus Sedation GmbH & Co. KG
NHP12HA
In Commercial Distribution

  • 04260635790592 ()


  • Anaesthesia face mask, single-use
Double Nasal Hood Single Use, Adult, Scent Chilla Vanilla 12 Hoods individually wrapped in a box. To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.
Baldus Sedation GmbH & Co. KG
NHA12CV
In Commercial Distribution

  • 04260635790585 ()


  • Anaesthesia face mask, single-use
Double Nasal Hood Single Use, Pediatric, Scent Chilla Vanilla 12 Hoods individually wrapped in a box To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.
Baldus Sedation GmbH & Co. KG
NHP12CV
In Commercial Distribution

  • 04260635790578 ()


  • Anaesthesia face mask, single-use
Double Nasal Hood Single Use, Adult, Scent Pure Ghost 12 Hoods individually wrapped in a box. To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.
Baldus Sedation GmbH & Co. KG
NHA12PG
In Commercial Distribution

  • 04260635790554 ()


  • Anaesthesia face mask, single-use
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