Low-Profile Angled Peg/Keel Drill

Low
REUNION - 5901-6086

A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: KWS

Device Name: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3660

Third Party Flag: N

Medical Specialty: OR

Code: HSD

Device Name: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3690

Third Party Flag: N

Medical Specialty: OR

Code: PHX

Device Name: Shoulder Prosthesis, Reverse Configuration

Device Class: 2

Physical State: Typically includes humeral stem, humeral socket, humeral cup, glenosphere, and glenoid baseplate with fixation screws. The humeral stem and humeral socket may be one single piece or two separate pieces locked together. The humeral cup is snap fit into the humeral socket. The humeral cup is made from UHMWPE and articulates with the glenosphere made of CoCrMo alloy, Titanium alloy, or stainless steel. The glenosphere locks to glenoid baseplate which is fixed to the glenoid bone by 2-6 screws. The glenoid baseplate has HA coating, metallic coating or no coating and may feature a central peg, central screw, central cage, or keel.

Definition: Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Relative to the native shoulder joint, the device moves the center of rotation medially and distally to the anatomic position which increases the length of the deltoid muscle's lever arm, allowing the same rotational moment with less applied force.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Shoulder joint

Regulation Number: 888.3660

Third Party Flag: N

Medical Specialty: OR

Device Id: 07613327293869

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A