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510(k) Data Aggregation
K Number
K251719Device Name
Momentum® Posterior Spinal Fixation System
Manufacturer
Ulrich Medical USA, Inc.
Date Cleared
2025-07-01
(27 days)
Product Code
NKB, KWP, PML
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Ulrich Medical USA, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K241396Device Name
uCerv Flux-C 3D Porous Titanium Cervical Interbody
Manufacturer
ulrich medical USA, Inc.
Date Cleared
2024-05-23
(7 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
ulrich medical USA, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The uCerv Flux ™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion. The hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Device Description
The uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants are additively manufactured interbody fusion devices for cervical implantation. The implants are designed having porous surfaces to provide surgical stabilization of the spine. Each interbody has a central cavity that can be packed with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material and lateral windows for radiographic visualization. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.
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K Number
K240515Device Name
uNion® MAX Cervical Plate System
Manufacturer
Ulrich Medical USA, Inc.
Date Cleared
2024-03-18
(24 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
Ulrich Medical USA, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The uNion MAX Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
Device Description
uNion MAX is an anterior cervical plate and screw system used to provide mechanical support across implanted level(s) in the cervical spine until fusion is achieved. The components include Ø4.0mm and Ø4.5mm fixed and variable screws having self-tapping, self-drilling or self-drilling/self-tapping tips and one- through four-level plates having lengths from 8mm to 84mm. The plates incorporate a pivoting locking mechanism which functions to block screw backout. The devices are sold non-sterile.
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