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510(k) Data Aggregation
K Number
K142661Device Name
Bi-Portal Bone Graft Delivery Device
Manufacturer
Spinal Surgical Strategies, LLC
Date Cleared
2014-12-11
(84 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Spinal Surgical Strategies, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bi-Portal Bone Graft Delivery Device is intended to be used for the delivery of hydrated allograft or autograft to an orthopedic surgical site.
Device Description
The Bi-Portal Bone Graft Delivery Device is comprised of a 21.0 cm length rectangular syringe barrel for surgical site access and bone graft material delivery; a compatible syringe plunger for pushing the allograft or autograft into the operative site; and, an attachable funnel reservoir for loading prepared material. The barrel has an 8.0 mm by 12.0 mm closed-end tapered distal shaft with a pair of longitudinal bilateral ejection holes near the distal end for material effusion into the surgical space. The barrel can be partially filled with up to 4.0 cc of material and refilled in-situ using the attachable funnel.
When used as an ancillary device to orthopedic surgical procedures that require the placement of autograft or allograft, the Bi-Portal Device can deliver a prepared amount of material. There are no luer lock components to the bi-portal design is intended to result in graft material effusion through the two laterally placed sideholes. This allows the material to be selectively placed within the surgical space adjacent to the Device barrel tip.
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