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510(k) Data Aggregation
K Number
K233154Device Name
SkyOPS Orthopedic Plate System
Manufacturer
Date Cleared
2023-12-21
(85 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Sky Surgical LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SkyOPSTM Orthopedic Plate System is indicated to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bone fragments of the foot. The system can be used in both adult and pediatric patients aged >12 years (adolescent, transitional adolescent B).
Device Description
The subject SkyOPS™ Orthopedic Plate System consists of various plates and screws that are used to stabilize and aid in the fusion or repair of fractures or osteotomies of small bones. The plates are offered in different lengths and sizes. The screws are offered in one diameter with different lengths. All implantable metal components are made from Ti-6Al-4V ELI per ASTM F136 or ASTM F3001. The devices are provided non-sterile to be cleaned and steam sterilized by the end user.
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