L-BUTTRESS RIGHT TIBIAL PLATE 4 HOLES W/PF HOLES

L
TC-100 - 71130904

A non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: HRS

Device Name: Plate, Fixation, Bone

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: 888.3030

Third Party Flag: N

Medical Specialty: OR

Device Id: 03596010459138

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