INITIA STEM HO #10

INITIA STEM HO #10
Initia Total Hip System - GMH02-500047

Device Description

A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Environmental Conditions

No Data Available

Device Sizes

Stem offset: 53mm

Neck length: 40mm

Stem length: 117mm

Taper: 12/14

Stem: High offset

Size: #10

Stem offset: 53mm
Neck length: 40mm
Stem length: 117mm
Taper: 12/14
Stem: High offset
Size: #10

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LPH

Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous 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: 888.3358

Third Party Flag: N

Medical Specialty: OR

Device Identifiers

Device Id: 04547898305078

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