Modal Total Hip System

GUDID B035M140000541

Trial Shell, Cluster Hole Sz 54

MODAL MANUFACTURING LLC

Acetabulum prosthesis trial, reusable

• Primary Device ID: B035M140000541
• NIH Device Record Key: a4e3e8c7-9502-44aa-98c3-4c649182960d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modal Total Hip System
• Version Model Number: M-1400-0054
• Company DUNS: 081983825
• Company Name: MODAL MANUFACTURING LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• 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
HIBCC	B035M140000541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143314

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

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

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

[B035M140000541]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-07-01

On-Brand Devices [Modal Total Hip System]

• B035MEBS65451: Bone Screw, 6.5mm X 45mm
• B035MEBS65401: Bone Screw, 6.5mm X 40mm
• B035MEBS65351: Bone Screw, 6.5mm X 35mm
• B035MEBS65301: Bone Screw, 6.5mm X 30mm
• B035MEBS65251: Bone Screw, 6.5mm X 25mm
• B035MEBS65201: Bone Screw, 6.5mm X 20mm
• B035MEBS65151: Bone Screw, 6.5mm X 15mm
• B035M150040011: Dome Impactor Sz 40
• B035M150036011: Dome Impactor Sz 36
• B035M150032011: Dome Impactor Sz 32
• B035M150028011: Dome Impactor Sz 28
• B035M150010171: Calcar Planar
• B035M150010161: Cup Alignment Guide
• B035M150010151: Shell Impactor Spacer
• B035M150010141: Handle, Straight Reamer
• B035M150010131: 3.5mm Pivot Driver
• B035M150010121: T-Handle Starter Awl
• B035M150010111: Osteo Cutter, Angled Box
• B035M150010101: Screw Forceps
• B035M150010091: Drill Guide
• B035M150010081: Flex Depth Gage
• B035M150010071: Flex Drill
• B035M150010061: Handle, Ratcheting In-Line
• B035M150010051: Handle, Straight Broach GBC
• B035M150010041: Handle, Head Impactor
• B035M150010031: Handle, Shell Impactor
• B035M150010021: Handle, Stem Extractor
• B035M150010011: Handle, Stem Impactor
• B035M143528041: Adapter, Trial 16/18 - 12/14 XL
• B035M143528031: Adapter, Trial 16/18 - 12/14 L
• B035M143528021: Adapter, Trial 16/18 - 12/14 M
• B035M143528011: Adapter, Trial 16/18 - 12/14 S
• B035M142507221: Trial Neck, Ext Sz 7.5 - 22.5
• B035M141040001: Femoral Option Head, Trial Sz 40
• B035M141036001: Femoral Option Head, Trial Sz 36
• B035M141032001: Femoral Option Head, Trial Sz 32
• B035M141028001: Femoral Option Head, Trial Sz 28
• B035M140022501: Taper Rasp, GBC Sz 22.5
• B035M140020001: Taper Rasp, GBC Sz 20.0
• B035M140015001: Taper Rasp, GBC Sz 15.0
• B035M140013751: Taper Rasp, GBC Sz 13.75
• B035M140012501: Taper Rasp, GBC Sz 12.5
• B035M140011251: Taper Rasp, GBC Sz 11.25
• B035M140010001: Taper Rasp, GBC Sz 10.0
• B035M140008751: Taper Rasp, GBC Sz 8.75
• B035M140007501: Taper Rasp, GBC Sz 7.5
• B035M140006221: Trial Neck, Std Sz 6.0 - 22.5
• B035M140006001: Taper Rasp, GBC Sz 6.0
• B035M140000681: Trial Shell, Cluster Hole Sz 68
• B035M140000661: Trial Shell, Cluster Hole Sz 66