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510(k) Data Aggregation
K Number
K222903Device Name
Tailored-H Cervical Stand Alone System
Manufacturer
BeSpoke Technologies, LLC
Date Cleared
2022-11-18
(56 days)
Product Code
OVE
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
BeSpoke Technologies, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tailored-H Cervical Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. The Tailored-H Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of nonoperative treatment. The Tailored-H Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.
Device Description
The Tailored-H Cervical Stand-Alone System is an internal spinal fixation system consisting of additively manufactured interbody devices and machined titanium bone screws. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tailored-H Cervical Stand-Alone System is available in a variety of lordosis and footprint options with a porous architecture to offer increased capacity for bone growth and mechanical properties to suit the individual pathology and anatomical conditions of the patient.
The Tailored-H cages are additively manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F3001. The fixation screws and face plates are machined from titanium alloy Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3.
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K Number
K200458Device Name
Tailored-C Cervical Interbody Fusion System
Manufacturer
BeSpoke Technologies
Date Cleared
2020-12-28
(307 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
BeSpoke Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tailored-C Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Tailored-C Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Tailored-C Cervical implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Device Description
The Tailored-C Cervical Interbody Fusion System is an intervertebral spinal fixation system comprised of additively manufactured cervical interbody spacers. They are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The implant has a partially porous construction and an open architecture with a large variety of footprints and lordosis angles to optimize patient fit. The footprints are offered at 11x13mm, 12x14mm, 14x16mm, 16x18mm, and 17x19mm. The lordosis is offered at 0°, 4°, and 7°. The height ranges from 5mm to 12mm in 1mm increments. All implant components are manufactured from Ti-6A1-4V per ASTM F3001.
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