Juveno™ Femoral Hip System 8819043737

GUDID 00843575102775

NECK TRIAL, HIGH OFFSET (127°), 37MM LENGTH

B-ONE ORTHO, CORP.

Femoral stem prosthesis trial

• Primary Device ID: 00843575102775
• NIH Device Record Key: b261932a-43f5-4d03-b56e-57ebb49a190c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Juveno™ Femoral Hip System
• Version Model Number: 8819043737
• Catalog Number: 8819043737
• Company DUNS: 081315444
• Company Name: B-ONE ORTHO, CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843575102775 [Primary]

FDA Product Code

• HWT: Template

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00843575102775]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-25
• Device Publish Date: 2019-03-15

On-Brand Devices [Juveno™ Femoral Hip System]

• 00843575106001: Femoral Broach Tray
• 00843575105998: Femoral General Tray
• 00843575104113: Sterilization Case
• 00843575103932: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 11, Standa
• 00843575103925: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 10, Standa
• 00843575103918: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 9, Standar
• 00843575103901: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 8, Standar
• 00843575103895: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 7, Standar
• 00843575103888: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 6, Standar
• 00843575103871: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 5, Standar
• 00843575103864: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 4, Standar
• 00843575103857: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 3, Standar
• 00843575103840: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 2, Standar
• 00843575103833: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 1, Standar
• 00843575103826: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 11, High (
• 00843575103819: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 10, High (
• 00843575103802: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 9, High (1
• 00843575103796: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 8, High (1
• 00843575103789: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 7, High (1
• 00843575103772: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 6, High (1
• 00843575103765: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 5, High (1
• 00843575103758: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 4, High (1
• 00843575103741: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 3, High (1
• 00843575103734: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 2, High (1
• 00843575103727: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 1, High (1
• 00843575102850: STRAIGHT BROACH HANDLE
• 00843575102843: T-HANDLE
• 00843575102836: NECK TRIAL, STANDARD OFFSET (132°), 40MM LENGTH
• 00843575102829: NECK TRIAL, STANDARD OFFSET (132°), 37MM LENGTH
• 00843575102812: NECK TRIAL, STANDARD OFFSET (132°), 35MM LENGTH
• 00843575102805: NECK TRIAL, STANDARD OFFSET (132°), 30MM LENGTH
• 00843575102799: NECK TRIAL, STANDARD OFFSET (132°), 27MM LENGTH
• 00843575102782: NECK TRIAL, HIGH OFFSET (127°), 40MM LENGTH
• 00843575102775: NECK TRIAL, HIGH OFFSET (127°), 37MM LENGTH
• 00843575102768: NECK TRIAL, HIGH OFFSET (127°), 35MM LENGTH
• 00843575102751: NECK TRIAL, HIGH OFFSET (127°), 30MM LENGTH
• 00843575102744: NECK TRIAL, HIGH OFFSET (127°), 27MM LENGTH
• 00843575102737: CORKSCREW
• 00843575102720: MODULAR HEAD IMPACTOR
• 00843575102713: AXIAL HANDLE
• 00843575102706: MODULAR BOX CHISEL
• 00843575102690: MALLET
• 00843575102683: CALCAR PLANER 32MM
• 00843575102676: STARTER REAMER
• 00843575102669: STEM IMPACTOR
• 00843575102652: STEM INSERTER, OFFSET
• 00843575102645: STEM REMOVER
• 00843575102638: FEMORAL RESECTION GUIDE
• 00843575100122: BROACH, SIZE 11
• 00843575100115: BROACH, SIZE 10