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510(k) Data Aggregation
K Number
K230794Device Name
Rebuilder Nerve Guidance Conduit
Manufacturer
CelestRay Biotech Company, LLC.,
Date Cleared
2024-01-29
(313 days)
Product Code
JXI
Regulation Number
882.5275Why did this record match?
Applicant Name (Manufacturer) :
CelestRay Biotech Company, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rebuilder Nerve Guidance Conduit is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.
Device Description
The Rebuilder Nerve Guidance Conduit is designed to be a permeable and bioresorbable poly(lactide-co-caprolactone) based tube. It is designed to serve as an interface between the nerve and the surrounding tissue, providing a protective environment for peripheral nerve repair after injury. The Rebuilder Nerve Guidance Conduit offers guidance and protection for axonal growth across a nerve gap. The Rebuilder Nerve Guidance Conduit is provided sterile, non-pyrogenic, for single use only, in various sizes (with product inner diameter ranging from 1.5mm to 10 mm). The Rebuilder Nerve Guidance Conduit is provided in double peel package.
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K Number
K222220Device Name
SpinMedix Absorbable Fibrous Membrane
Manufacturer
CelestRay Biotech Company, LLC
Date Cleared
2023-07-06
(346 days)
Product Code
OWW, FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
CelestRay Biotech Company, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SpinMedix Fibrous Membrane is indicated for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Device Description
SpinMedix Absorbable Fibrous Membrane provides a non-constricting protective layer between the injured tissue and surrounding tissues and may be secured in place using standard fixation techniques. It is designed for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. SpinMedix is composed of poly (D, L-Lactide-co- Glycolide) and poly (D, L-Lactideb-Ethylene Glycol), and is provided in a variety of sizes, ranging from 25mm * 25mm to 200mm * 300mm. It is a single use, sterilized, porous, polymeric membrane in double peel packages.
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