Search Results
Found 5 results
510(k) Data Aggregation
K Number
K191771Device Name
SECURE Screw
Manufacturer
A.M. Surgical, Inc.
Date Cleared
2019-10-16
(106 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
A.M. Surgical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SECURE Screw is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Device Description
The A.M. Surgical SECURE Screw is a stainless steel, cannulated, partially threaded, headless screw intended to be used for fracture fixation of small, long bones of the hands and feet. Screw threads provide compression to promote reunion of fracture fragments. The device is offered in five different lengths; 40mm, 45mm, 50mm, 55mm, and 60mm. All dimensions, excluding length, are the same among the different sizes. These varying lengths allow for personalized medical treatment of fractures geared toward each individual patient and different types of fractures. The device is manufactured out of a single piece of 316L VM (UNS-S31673) stainless steel, is provided sterile (via gamma radiation), and is not reusable or re-sterilizable. This device is intended for permanent implantation, but can also be removed. To install and remove the device from a patient, the F543 compliant T8 hexalobe drive connection on the screw head is used in conjunction with a commercially available guide wire, drill bit, and driver.
Ask a Question
K Number
K191345Device Name
Pegasus System
Manufacturer
A.M. Surgical, Inc.
Date Cleared
2019-07-17
(58 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
A.M. Surgical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pegasus System is indicated for diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
Device Description
The Pegasus System is a portable, disposable, rigid, video camera enabled handheld probe paired with a wireless video receiver. It is powered by internal batteries encased in a plastic handpiece/handle. The distal tip of the stainless steel probe contains a camera and LED light source for visualization. The device is provided sterile and is intended for single patient use.
Ask a Question
K Number
K080133Device Name
MOUNTABLE ENDOSCOPIC BLADE
Manufacturer
A.M. SURGICAL, INC.
Date Cleared
2008-03-13
(55 days)
Product Code
EMF
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
A.M. SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mountable Endoscopic Blade is indicated for use in minimally invasive ligament or fascia release.
- Carpal tunnel release for carpal tunnel syndrome .
- Plantar fasciotomy for plantar fasciitis .
- Lateral release of the knee for extensor mechanism malalignment .
- Forearm fasciotomy for compartment syndrome
- . Morton's neuroma for interdigital neuroma
- Gastrocnemius release for heel cord contracture (equinus) .
Device Description
The Mountable Endoscopic Blade is a device that mounts to a 4mm 30° endoscope.
Ask a Question
K Number
K042458Device Name
A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
Manufacturer
A.M. SURGICAL, INC.
Date Cleared
2004-10-07
(27 days)
Product Code
LXT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
A.M. SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is to be used for external stabilization of open and/or unstable fractures of the distal radius were soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.
Device Description
A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is an external wrist fixator made of titanium , consisting of two (distal and proximal) connecting slide sections with predetermined angled holes. Standard Kirschner wires (K-wire) are inserted through the predetermined angle holes for fracture fixation, three on the distal section and two on the proximal section. The sections can be adjusted distal to proximal and locked into place by way of a center hex screw. The device will be offered sterile and is single use.
Ask a Question
K Number
K982142Device Name
MOUNTABLE ENDOSCOPIC KNIFE
Manufacturer
A.M. SURGICAL, INC.
Date Cleared
1998-12-30
(196 days)
Product Code
EMF
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
A.M. SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
a) Carpal tunnel release / carpal tunnel syndrome
b) plantar fasciotomy/ Plantar fascitis
c) lateral release of the knee / extensor mechanism malignment
d) forearm fasciotomy / compartment syndrome
e) Mortons Neuroma/ Interdigital Neuroma
Device Description
Mountable Endoscopic Knife
Ask a Question
Page 1 of 1