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510(k) Data Aggregation
K Number
K242348Device Name
Locking Screw,CoCrMo
Manufacturer
Double Medical Technology Inc.
Date Cleared
2024-12-04
(118 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Double Medical Technology Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Locking Screw,CoCrMo is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.
Device Description
Locking Screw, CoCrMo is used to fasten plates onto bones, or, as lag screws, to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Locking Screw, CoCrMo consists of a series of screws with different sizes and structures, which is designed according to the anatomical characteristics of human bones. In clinical practice, the bone screw shall be used in combination with the bone plate, which acts as a temporary internal support, provides a stable local environment for the fractured end, and creates conditions for the healing of the fractured end. Locking Screw,CoCrMo is made of CoCrMo following ASTM F1537. Locking Screw,CoCrMo is provided as sterile and non-sterile. The implants are intended for single-use only.
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K Number
K233078Device Name
Posterior Cervical Spine System
Manufacturer
Double Medical Technology Inc.
Date Cleared
2023-11-22
(58 days)
Product Code
NKG, KWP
Regulation Number
888.3075Why did this record match?
Applicant Name (Manufacturer) :
Double Medical Technology Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Posterior Cervical Spine System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T2:
(1)Traumatic spinal fractures and/or traumatic dislocations.
(2)Instability or deformity.
(3)Failed previous fusions (e.g. pseudarthrosis).
(4)Tumors involving the cervical spine.
(5)Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
Device Description
The Posterior Cervical Spine System consists of pedicle screws, nut, rods, connectors, hook, transconnectors, laminar hooks, occipital plates and occipital screw.
The implants in Posterior Spine Cervical System is made from Ti-6A1-4V ELI following ASTM F136 or Ti-6Al-4V following ASTM F1472.
The implants are provided as sterile or non-sterile, while the instruments are provided as non-sterile.
The implants are intended for single-use only, while the instruments are reusable.
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K Number
K223753Device Name
Cervical Plate System
Manufacturer
Double Medical Technology Inc.
Date Cleared
2023-03-14
(90 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
Double Medical Technology Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1 and is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2)trauma (including fractures); 3)tumors: 4)deformity(defined as kyphosis, lordosis,or scoliosis); 5)pseudoarthrosis; 6)failed previous fusions
Device Description
Cervical Plate System consist of anterior cervical spine plate II, anterior cervical spine plate IV and screws. The anterior cervical spine plate is fixed to the front of the cervical vertebrae by screws to play an auxiliary role in maintaining the stability of the surgical segment and preventing the fusion implant from coming out. Screws are available for fixed angle or variable angle implantation.
Bone plates in Cervical Plate System are made of unalloyed titanium following ASTM F67 and titanium alloy following ASTM F1472 as well as ASTM F1295, and bone screws in Cervical Plate System are made of titanium alloy following ASTM F136.
Cervical Plate System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
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K Number
K221150Device Name
Advanced Bone Plate
Manufacturer
Double Medical Technology Inc.
Date Cleared
2023-01-25
(280 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Double Medical Technology Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Advanced Bone Plate (AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM, ITVAL Foot & Ankle VAL System, and Distal Fibular VAL Plate) is internal fixation. Specific indications for the plates included in the system as follows:
The AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM is inticated for the internal fixation (fractures, osteotomies, arthrodesis, replantations and reconstructions) of the hand (metacarpals and phalanges) and wrist of adults and adolescents (age 12-21 years) in which growth plates have fused or will not be crossed by fixation.
The ITVAL Foot & Ankle VAL System is internal fixation (fractures, osteotomies, fusions, nonunions, malunions, small fragment replantations) of the foot and ankle in adults and adolescents (age 12-21 years) possessing normal or osteopenic bone where growth plates have fused or will not be crossed by fixation.
The Distal Fibular VAL Plate is indicated for internal fractures, osteotomies, nonunions, malunions, small fragment replantations) of the distal fibula of adults and adolescents (age 12-21 years) where growth plates have fused or will not be crossed by fixation.
Device Description
Advanced Bone Plate is mainly used for internal fixation of hand, wrist, foot, ankle and distal fibular fractures. According to the anatomical characteristics of human bones, locking plates of different shapes and locking screws of different diameters are designed. In clinical practice, locking bone plate and locking bone screw are used in combination to play the role of temporary internal stent, providing a stable local environment for fracture ends and creating conditions for the healing of fracture ends.
Bone plates in Advanced Bone Plate are made of titanium alloy following ASTM F1472, and bone screws in Advanced Bone Plate are made of titanium alloy following ASTM F136. Advanced Bone Plate is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
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K Number
K221088Device Name
Anatomic Bone Plate
Manufacturer
Double Medical Technology Inc.
Date Cleared
2023-01-18
(280 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Double Medical Technology Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anatomic Bone Plates are intended for the internal fixation of fractures (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral, Distal Ulnar Locking, Distal Radial Locking, VAL Proximal Tibia, VAL Distal Tibia, VAL Distal Lateral Fibular, VAL Distal Femoral, Pelvic Bone Plate), fracture dislocations (VAL Proximal Humeral), osteotomies, and mal/non-unions (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral) of the clavicle, pelvis, and the upper (i.e., humerus, ulna and radius) and lower (i.e., femur, tibia, and fibula) extremities. Additional plates included in the system with specific indications as follows:
- A VAL (Variable Angle Locking) Distal Clavicle Plate is indicated for fractures of the shaft and lateral clavicle, malunions and non-unions ;
- > VAL Distal Humeral Plate is indicated for fractures (including supracondylar), and nonunions :
- A VAL Distal Femoral Plate is indicated for distal femoral fractures (diaphyseal, supracondylar, and intra-articular);
- > Pelvic Bone Plate is indicated for pelvic fractures (e.g., acetabular , iliac wing, and symphysis pubis).
Device Description
Anatomic Bone Plate is mainly used for internal fixation of fracture. According to the anatomical characteristics of human bones, locking plates of different shapes and locking screws of different diameters are designed. In clinical practice, locking bone plate and locking bone screw are used in combination to play the role of temporary internal stent, providing a stable local environment for fracture ends and creating conditions for the healing of fracture ends. Anatomic Bone Plate is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
Anatomic Bone Plate are made of titanium alloy following ASTM F1472 or unalloyed titanium following ASTM F67.
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K Number
K221090Device Name
Metal Cannulated Screw
Manufacturer
Double Medical Technology Inc.
Date Cleared
2023-01-10
(272 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Double Medical Technology Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Metal Cannulated Screw is indicated for internal fixation of fracture, fusion and correction of limb bone and metaphysis, hand and foot:
1)The 2.3mm No Profile Cannulated Screw is indicated for the fixing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
2)The 3.0mm No Profile Cannulated Screw is indicated for internal fixation of bone fractures of ulna, and small bones (metacarpals, metatarsals, and phalanges).
3)The 4.0mm No Profile Cannulated Screw and 4.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of small bones and small bone fragments.
4)The 5.0mm No Profile Cannulated Screw and 5.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, and the bones of the hand and foot.
5)The 7.0mm No Profile Cannulated Screw and 7.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capiplysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis.
6)The Headless Cannulated Screw (2.5-4.5mm)/Headless Compression Screw (2.5-4.5mm) are indicated for fixation of fractures in large bones of humerus, ulna, radius, tibia and fibula, and small bones of the foot. These screws are also indicated for intra-articular fractures of knee and ankle joint.
7)The Headless Cannulated Screw (5.0-7.0mm)/ Headless Compression Screw (5.2-7.0mm) are indicated for fixation of fractures of femur, tibia and calcaneus, and intra-articular fractures of knee joint.
8)The 3.5mm/4.0mm Headless Compression Screw, Oblique are indicated for fixation of bone fractures or for bone reconstruction of the foot and hand, including calcaneus, talar, navicular, metacarpals, metatarsals and phalanges.
9)The 6.5mm Cannulated Screw are intended for fixation of fractures, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capital femoral epiphysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis.
10)The 7.3mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, pelvis, sacrum and the bones of the foot. These screws are also indicated for slipped capital femoral epiphysis, ankle arthrodesis and subtalar arthrodesis.
Device Description
Metal Cannulated Screw consists of a series of screws with different sizes and structures, which is designed according to the anatomical characteristics of human bones. In clinical practice, Metal Cannulated Screw is used alone, which acts as a temporary internal support, provides a stable local environment for the fractured end, and creates conditions for the healing of the fractured end. Metal Cannulated Screw are made of Ti-6Al-4V ELI following ASTM F 136. Metal Cannulated Screw is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
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K Number
K221221Device Name
Advanced Intramedullary Nail System
Manufacturer
Double Medical Technology Inc.
Date Cleared
2022-12-21
(238 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
Double Medical Technology Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Advanced Intramedullary Nail System is intended to be implanted into the medullary canal of limbs for alignment. stabilization, fixation of fractures caused by trauma or diseases.
Indications:
1. Ulna Nail: Indicated for the fixation of fractures and osteotomies of the ulna.
2.Fibular Nail: Indicated for fixation of fractures and osteotomies of the fibula.
3. Ankle Fusion Nail: Indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot: tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and subtalar joints; avascular necrosis of the ankle and subtalar joints; failed total ankle replacement with subtalar intrusion;failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the subtalar joints.
Device Description
The method of intramedullary nail fixation is symmetrical central splint fixation; central fixati on is theoretically superior to cortical external fixation, which can reduce the moment arm, re duce the incidence of varus and valgus angulation and internal fixation failure. Intramedullary nail fixation of fractures is stress-distributed fixation rather than stress-shielded fixation, whi ch is beneficial to the plasticity of callus. Advanced Intramedullary Nail System are made of Ti-6Al-4V ELI following ASTM F136. Advanced Intramedullary Nail System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
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K Number
K220921Device Name
Metal Bone Screw
Manufacturer
Double Medical Technology Inc.
Date Cleared
2022-12-12
(257 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Double Medical Technology Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Metal Bone Screw is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.
Device Description
Metal Bone Screw are used to fasten plates onto bones, or, as lag screws, to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Metal Bone Screw consists of a series of screws with different sizes and structures, which is designed according to the anatomical characteristics of human bones. In clinical practice, the bone screw can be used alone or in combination with the bone plate, which acts as a temporary internal support, provides a stable local environment for the fractured end, and creates conditions for the healing of the fractured end. Metal Bone Screw are made of Ti-6A1-4V ELI following ASTM F136. Metal Bone Screw is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
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K Number
K172830Device Name
Double Medical Femoral Nail System
Manufacturer
Double Medical Technology Inc.
Date Cleared
2018-08-24
(340 days)
Product Code
HSB, HWC
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
Double Medical Technology Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Double Medical Femoral Nail System is intended for femoral fracture fixation and promoting femoral fracture healing.
Indications for use of the Proximal Femoral Nail, Anti-rotation, short; and Anatomical Proximal Femoral Nail (APFN ), short (Length 170 mm - 240 mm) include:
- Pertrochanteric fractures (31-A1 and 31-A2);
- Intertrochanteric fractures (31-A3);
- High subtrochanteric fractures (32-A1).
Indications for use of the Proximal Femoral Nail. Anti-rotation. long (Length 300 mm - 420 mm), Anatomical Proximal Femoral Nail (APFN ), long (Length 300 mm - 480 mm) include:
- Low and extended subtrochanteric fractures;
- Ipsilateral trochanteric fractures;
- Combination fractures (in the proximal femur);
- Pathological fractures.
Indications for use of the Universal Femoral Nail, Cannulated (UFN I) include:
- Femoral shaft fractures.
Indications for use of the Universal Femeral Nail II, Cannulated (UFN II) include:
- Standard Locking UFN II: femoral shaft fractures;
- Reconstruction Locking UFN II : femoral shaft combined with femoral neck fractures, subtrochanteric fractures.
Device Description
Double Medical Femoral Nail System consists of a series of nails, spiral blades, locking screws, end caps and related instrument. The implants are provided in a variety of lengths and anatomical designs to accommodate the medullary canal of femur. All of the implants in the Double Medical Femoral Nail System are made of made of Ti-6AI-4V following ISO 5832-3 or Ti-6Al-4V ELI following ASTM F 136, which are widely used for surgical implants with well-known biocompatibility. Double Medical Femoral Nail System is provided as non-sterile.
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K Number
K172828Device Name
Double Medical Cage System
Manufacturer
Double Medical Technology Inc
Date Cleared
2018-02-01
(136 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Double Medical Technology Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Double Medical Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to L5 whose condition requires the use of interbody fusion combined with supplemental fixation. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Cage should be packed with autogenous bone graft (i.e. autograft).
Device Description
Double Medical Cage System consists of cages of various lengths and heights, which can be inserted between two vertebral bodies to give support during interbody fusion surgeries. The cages consist of main bodies and marker pins. The main bodies are made of PEEK, which meets the requirements of ASTM F 2026-02 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. Marker pins are made of Ti-6Al-4V following ASTM F 1472-14 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Allov for Surgical Implant Applications.
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