AZUL HEAD 36 +3.5

AZUL HEAD 36 +3.5
BIOCERAM AZUL HEAD - GMH04-400067

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 ceramic-on-polyethylene or cross-linked polyethylene (PE) 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

Taper: 12/14

Offset: +3.5mm

Size: φ36MM O.D.

Taper: 12/14
Offset: +3.5mm
Size: φ36MM O.D.

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LZO

Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-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: 888.3353

Third Party Flag: N

Medical Specialty: OR

Device Identifiers

Device Id: 04547898308185

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