3.2MM THREADED PIN 55MM W/ COLLAR 4/PK

3.2MM THREADED PIN 55MM W/ COLLAR 4/PK
ENGAGE - 1-50100-455

Device Description

A small non-sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device intended to be sterilized prior to use.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

Moist Heat or Steam Sterilization

Moist Heat or Steam Sterilization

Product Codes

Code: NJD

Device Name: Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

Device Class: 2

Physical State: N/A

Definition: Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.

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: 888.3535

Third Party Flag: N

Medical Specialty: OR

Code: HSX

Device Name: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

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: 888.3520

Third Party Flag: N

Medical Specialty: OR

Device Identifiers

Device Id: 20885556875142

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00885556875148

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BX

Device Id: 00885556875148

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