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Found 4 results
510(k) Data Aggregation
K Number
K163440Device Name
Stealth Staple System
Manufacturer
FIRST RAY LLC
Date Cleared
2017-02-01
(55 days)
Product Code
JDR, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
FIRST RAY LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stealth Staple System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:
- Arthrodesis in hand or foot surgery ●
- Mono or bi-cortical osteotomies in the foot or hand ●
- Fracture management in the foot or hand ●
- . Distal or proximal metatarsal or metacarpal osteotomies
- Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc. .
Device Description
The Stealth Staple System fixes bone fractures and osteotomies and achieves joint fusion by engaging two bone fragments and holding them together.
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K Number
K153585Device Name
Flip Button Suture Anchor
Manufacturer
FIRST RAY LLC
Date Cleared
2016-05-05
(141 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
FIRST RAY LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The First Ray Flip Button Suture Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, and wrist. Specific indications are listed below:
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP Joints for All Digits, Digital Tendon Transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction
Device Description
The Flip Button Suture Anchor is a device which is preloaded with suture and is designed to attach soft tissues to bone. The device is deployed through a bicortical drill hole and secured on the far cortex.
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K Number
K153638Device Name
Bicortical Fixation Screw & Washer Nut System
Manufacturer
FIRST RAY LLC
Date Cleared
2016-04-19
(123 days)
Product Code
HWC, HTN
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
FIRST RAY LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bicortical Fixation Screw & Washer Nut System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
Device Description
The Bicortical Fixation Screw & Washer Nut System consists of screws in various diameters and lengths that mate with a washer nut to achieve bicortical fixation.
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K Number
K153622Device Name
First Ray Internal Bone Staple System
Manufacturer
FIRST RAY LLC
Date Cleared
2016-04-08
(112 days)
Product Code
JDR, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
FIRST RAY LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The First Ray Internal Bone Staple System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:
- · Arthrodesis in hand or foot surgery
- · Mono or bi-cortical osteotomies in the foot or hand
- · Fracture management in the foot or hand
- · Distal or proximal metatarsal or metacarpal osteotomies
- · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.
Device Description
The Internal Bone Staple System fixes bone fractures and osteotomies and achieves joint fusion by engaging two bone fragments and holding them together.
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