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510(k) Data Aggregation
K Number
K250470Device Name
Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
Manufacturer
Shenzhen AOJ Medical Technology Co., Ltd.
Date Cleared
2025-06-23
(125 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen AO**J **Medical Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ear Thermometer is intended to measure human body temperature of people over three months from surface of eardrum. It applies to both professional use and home use.
Device Description
The ear thermometer is a handheld device that displays the temperature of the measured patient by measuring the thermal radiation of the eardrum. Measurement unit: °C or °F. The results can be displayed on LCD. The thermometers are powered by 1.5V×2 (AAA or AA) alkaline batteries, which can be used for people over three months. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum, which is converted into temperature measurement with the unit of °C or °F. All the models share the same critical components, intended use, working principle and similar product design, and compose of a sensor, PCB, buttons, LCD display and housing. Functions include temperature measurement, memory reading recall, unit switch, low battery detection and high temperature indicator.
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K Number
K250161Device Name
Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo
Manufacturer
Shenzhen AOJ Medical Technology Co., Ltd.
Date Cleared
2025-05-02
(101 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen AO**J **Medical Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wrist Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique by an inflatable cuff wrapped around the wrist at medical facilities or at home.
Device Description
The Wrist Blood Pressure Monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or Kpa.
All the models included in this submission follow the the same intended use, same measurement principle, same blood pressure core algorithm and similar product design. All the models can be used with one cuff size 13.5~19.5 cm (5.3-7.7inches).
The main differences are appearance, Dimensions and some specifications which will not affect the safety and effectiveness of the device.
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K Number
K244000Device Name
Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);
Manufacturer
Shenzhen AOJ Medical Technology Co., LTD
Date Cleared
2025-04-30
(125 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen AO**J **Medical Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm at medical facilities or at home.
Device Description
The Arm Blood Pressure Monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or Kpa.
The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The device also has low voltage indication, which will be triggered when the battery is low.
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K Number
K250116Device Name
Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)
Manufacturer
Shenzhen AOJ Medical Technology Co., Ltd
Date Cleared
2025-04-24
(98 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen AO**J **Medical Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm at medical facilities or at home.
Device Description
Arm blood pressure monitor, models(models ARM-30H, ARM-30J, ARM-30K and AOJ-90B), are designed as a battery driven automatic no-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or Kpa. All the models included in this submission follow the similar software, same measurement principle and same specifications. All the models can be used with one cuff size 22~42 cm (8.6~16.5 inches). AOJ90B has extra 4G network except for other models.
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K Number
K240563Device Name
Power Wheelchair (JJW-6001)
Manufacturer
ZheJiang J&J Mobility Co., Ltd
Date Cleared
2024-10-08
(222 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
ZheJiang J&**J **Mobility Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Device Description
This Power Wheelchair, model: JJW-6001, is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, seatbelt, pedal, battery box and charger. The device is powered by Li-ion Battery pack with 16 Km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use. The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
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K Number
K240837Device Name
TOV Dental Implant System
Manufacturer
RDJ TOV Implant Ltd
Date Cleared
2024-08-15
(141 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
RD**J **TOV Implant Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TOV Dental Implant System are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Maer, Ragil and TCX are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Ragil 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.
Device Description
The TOV Dental Implant System contains 2 designs of internal hex implants and various types of abutments as described below as well as 1 design of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments other than UCLA abutments are intended to be modified by the user.
Maer implants are tapered internal hex implants with more tightly spaced flat edge threads at the top and wider spaced flat edge threads in the lower tapered section. Maer comes in 3.5, 3.75, 4.2, 5.0 and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm in 6.0mm diameter).
Ragil implants are cylindrical internal hex implants with evenly spaced threads which are flat edged at the top and sharp edged in the lower section. Ragil comes in 3.3, 3.75, 4.2, 5.0, and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm in 5.0 or 6.0mm diameter). 3.3mm diameter implants are not for use with angled abutments in the posterior region of the mouth.
Internal Hex Healing Abutments come in 4.5mm diameter with cuff heights of 2, 3, 4, 5, 6,7 mm. They come in narrow with a diameter 3.8mm with cuff heights of 3, 4, 5,6, 7 mm and wide with a diameter 5.5mm with cuff heights of 2,3,4,5,6,7 mm. Extra wide healing caps are 6.3mm diameter and come in cuff heights of 2,3,4,5 mm. An internal hex cover screw is also available. A healing cap for multi-units is available.
Internal Hex Straight Abutments have a 3.75mm interface diameter and come in 4.5mm diameter with total heights above the platform of 5,7,9,11,13,15 mm, and in 5.5mm diameter with heights above the platform of 9, 11, and 13 mm.
Internal Hex Straight Narrow Abutments have a 3.75mm interface area and come 3.75mm diameter with heights above the platform of 5,7,9, 11 mm.
Internal Hex Straight Shouldered Abutments come in 3.75mm interface diameter in 4.5 and 5.4 mm diameter with gingival heights of 1,2,3,4 mm.
Internal Hex Angled Abutments come in 15° 3.75mm diameter with height above platform of 9, and 11.4mm, and 25° 3.75mm diameter with height above platform of 8.5 mm.
Internal Hex Angled Anatomic Abutments come in 15° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above low side of shoulder of 8,9,10,11 mm and 25° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above platform of 8.3, 9.2, 10.3, 10.3 mm.
Internal Hex UCLA abutment bases come in 3.75mm diameter and use a Delrin plastic sleeve. The UCLA are for making straight restorations which are 4mm above the gingival collar and have a post height of no more than 12mm. The minimum wall thickness of the cast abutments is 0.3mm. The angulation, wall thickness and diameter of the UCLA base component are not intended to be modified.
Internal Hex Ball attachments come in 4.0mm diameter with cuff heights of 2, 3, 4, 5, 6, or 7mm.The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.
Internal Hex Double Loc Attachments come in 3.85mm diameter with cuff heights 1,2,3,4,5,6 mm. The Double Loc attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.
Internal Hex Straight Multi-Unit come in 4.8mm diameter with cuff heights of 1, 2, 3, 4, 5 mm.
Internal Hex Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.
TCX implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. TCX comes in 3.5 (NP), 4.3 (RP) and, 5.0 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16mm.
Conical healing caps come in NP and RP with cuff heights of 2,3,4,5 mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available.
Conical straight abutments come in NP and RP with heights above platform of 9 or 13 mm.
Conical shoulder abutments come in NP and RP with gingival heights of 1,2,3 mm.
Conical angled shoulder abutments 15° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.
Conical angled shoulder abutments 25° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.
Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.
Conical Retentor attachments in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. The Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.
Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm.
Conical NP and RP Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.
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K Number
K232989Device Name
Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)
Manufacturer
Shenzhen AOJ Medical Technology Co., Ltd
Date Cleared
2024-07-01
(283 days)
Product Code
DQA, DOA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen AO**J **Medical Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in home and healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
Device Description
The Pulse Oximeter is a battery powered device in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 m, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The device mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, Bluetooth® module and plastic shell. There are five models AOJ-70A, AOJ-70C, AOJ-70E. Only AOJ-70E. Only AOJ-70D have wireless connection function via Bluetooth®. The device is a spot-check pulse oximeter and does not intended for life-supporting or life-sustaining.
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K Number
K233913Device Name
Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)
Manufacturer
AOJ Health Technology Co., Ltd.
Date Cleared
2024-05-14
(154 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
AO**J **Health Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K231132Device Name
J & P Click Attachments
Manufacturer
J & P Dental Technologies
Date Cleared
2024-03-26
(340 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
**J **& P Dental Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
J & P Click Attachments are designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. They are used in fixed hybrid restorations that can be attached with a click in system. Click attachments are indicated for use with vertical implant placements. They are indicated for the following implant systems: Biohorizons Tapered Tissue Level implants in diameters 3.8, 4.2, 4.6, 5.2 mm Nobel Biocare NobelActive including 3.5. 4.3, 5.0 mm diameter NobelActive, 3.75, 4.3, 5.0mm diameter NobelParallel and 3.5. 4.3. 5.0mm diameter NobelReplace Conical Connection Implants Implant Direct Legacy 3 for 3.7, 4.2, 4.7, 5.2mm diameter implants Surgikor Versatile for 3.5, 3.75, 4.2, 4.5, 5.0, 6.0mm diameter implants Surgikor Fixation for 3.5. 3.9. 4.3. 5.0mm diameter implants Surgikor Solution for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0mm diameter implants Neodent Grand Morse for 3.5, 3.75, 4.0, 4.3 and 5.0 mm diameter implants MIS Seven for implant diameters 3.75, 4.2, 5, and 6mm Zimmer for Tapered Screw-Vent in 3.7, 4.1 and 4.7mm implant diameter Hiossen ETIII for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, and 7.0mm implant diameters SIN Cone Morse 11.5° and 16° implant lines 11.5° Strong SW/SW Plus implant diameters 3.5. 3.8.4.5. 5.0mm Unitite implant diameters 3.5. 4.0.4.3. 5.0. 6.0 Tryon CM Conical implant diameters 3.5, 4.5, 5.0 Tryon CM Cylindrical implant diameters 3.5, 3.75, 4.0. 5.0 Epikut CM/CM Plus implant diameters 3.5, 3.8, 4.0. 4.5, 5.0 16 ° Strong SW CM Plus implant diameters 3.5, 3.8, 4.5 and 5.0mm Epikut S/S Plus implant diameters 3.5, 3.8. 4.0. 4.5. 5.0mm
Device Description
J & P Click Attachments provide a rigid connection of fixed, partial and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. They consist of abutments, attachment housings, and inserts. The abutments are provided in various OEM implant and abutment connections. The abutments are made from Ti-6AL-4V ELI which meets ASTM F136. All varieties of click attachments come in collar heights of 1, 2, 3, 4, 5 and 6mm. Abutment platform diameters include: Biohorizons 3.5, and 4.5mm Nobel Biocare Nobel Active 3.5 and 3.9mm (NobelParallel and NobelReplace Conical Connection are the same) Implant Direct Legacy 3.5 and 4.5mm Surgikor Versatile 3.5 and 4.5mm Surgikor Fixation and Solution 3.5 and 3.9mm Neodent Grand Morse 3.0mm MIS Seven 3.5 and 4.5mm Zimmer for Tapered ScrewVent 3.5 and 4.5mm Hiossen ETIII 3.35mm SIN 2.5mm for 11.5° cone morse and 2.72 mm for 16° cone morse
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K Number
K232877Device Name
FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C Stand Alone System
Manufacturer
K&J Consulting Corporation
Date Cleared
2023-12-13
(89 days)
Product Code
MRW, HWC, ODP, OUR, OVE, PEK
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
K&**J **Consulting Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw System is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The FaSet Fixation System is indicated for treatment for any or all of the following:
- Spondylolisthesis
- Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity
- Spondylolysis
- Degenerative Disk Disease (DDD) as defined by back pain of discogenic origin with degeneration of disk confirmed by history and radiographic studies and/or degenerative disease of the facets with instability
- Trauma including spinal fractures and/or dislocations.
The UNITY Sacroiliac Joint Fixation System is indicated for sacroiliac joint fusion for:
- Sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint disruptions
- Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion
The UNITY Sacroiliac Joint Fixation System is also indicated for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The Huvex Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device intended for use in the lumbar spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), tumor, and/or lumbar spinal stenosis. The Huvex Interspinous Fixation System is intended for use, in conjunction with autogenous bone graft, and not intended for stand-alone use.
The AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used.
Device Description
The FaSet Fixation System consist of permanent implant devices manufactured from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, and F136. Various sizes and lengths of these implants are available to accommodate patient anatomy. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.
The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac joint fusion. The UNITY Sacroiliac Joint Fixation System is offered in various diameters, lengths, and three screw types in cannulated form to accommodate patient anatomy and is manufactured from titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F136 and cobalt chrome alloy as specified in ASTM F1537. The three design types of the subject device are:
- 1. Standard Thread Screw (with and without slots)
- 2. Lag Screw (with and without slots) and
- 3. Washer Screw (with slots)
The Huvex Interspinous Fixation System consists of a left plate, a right plate, pin, bolt, inner cap, center bar, and set screw. Each of these components is provided in several sizes to allow for the construction of five different HUVEX Interspinous Fusion implant sizes. The left plate is provided assembled with the poly axial bar. The bar has a bone graft window to allow fusion between spinous process. Poly axial bar is also designed to fit the anatomical characteristics of the spinous process. The right plate is designed to be combined with left plate fixed to spinous process. Right plate contains a set screw to lock the right plate to the poly axial bar. The Huvex Interspinous Fixation System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.
In addition to the implants a set of reusable surgical instruments are provided. Both implant and instruments have trays that are used for handling and storage.
The AEON-C™ Stand Alone System includes PEEK interbodies and titanium interbodies, which utilize a titanium alloy locking mechanism that is either integrated in an anterior fixation plate or within the interbody. Both PEEK interbodies and titanium interbodies, with or without fixation plates, are to be anchored to patient anatomy via two (2) titanium alloy bone screws. The implant design includes multiple footprints, heights and lordosis options and the screw design includes multiple diameters and lengths, to fit a variety of patient anatomies. The interbodies can be used without the provided screws when supplemental fixation is used.
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