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Height Adjustable Driver
L&K BIOMED CO. ,LTD.
BT01-0002
In Commercial Distribution
- 08809986466440 ()
- Orthopaedic prosthesis implantation positioning instrument, reusable
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
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
T-25 Drive Shaft, Long
Altus Spine, LLC
908-0052
In Commercial Distribution
- 00843210134611 ()
- Surgical screwdriver, reusable
T-25 Removable Tip, Tapered
Altus Spine, LLC
905-1955
In Commercial Distribution
- 00843210134567 ()
- Surgical screwdriver, reusable
T-25 Final Drive Shaft
Altus Spine, LLC
905-1011
In Commercial Distribution
- 00843210134550 ()
- Surgical screwdriver, reusable
PSS: Screwdriver
Altus Spine, LLC
900-1024
In Commercial Distribution
- 00843210134369 ()
- Surgical screwdriver, reusable
PSS: Disposable Tip
Altus Spine, LLC
900-1019
Not in Commercial Distribution
- 00843210134314 ()
- Surgical screwdriver, single-use
PSS: Cross Connector Cam Drive
Altus Spine, LLC
900-1016
In Commercial Distribution
- 00843210134307 ()
- Surgical screwdriver, reusable
Large Slap Hammer
Altus Spine, LLC
780-0023
In Commercial Distribution
- 00843210134147 ()
- Surgical mallet