Humelock II Cementless Shoulder System 107-4536

GUDID 03701037302019

Humelock II Cementless Shoulder System, CORTICAL SCREW TA6V Ø4.5mm L.36mm

FX SOLUTIONS

Shoulder prosthesis screw

• Primary Device ID: 03701037302019
• NIH Device Record Key: 39c22445-4719-4415-b4c0-dcfa182312a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Humelock II Cementless Shoulder System
• Version Model Number: LENGTH 36 mm
• Catalog Number: 107-4536
• Company DUNS: 263076196
• Company Name: FX SOLUTIONS
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com
• Phone: +33474553397
• Email: jjmartin@fxsolutions.com

Device Dimensions

• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter
• Length: 36 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701037302019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130759

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-08
• Device Publish Date: 2016-06-09

On-Brand Devices [Humelock II Cementless Shoulder System]

• 03701037307212: HUMELOCK K-WIRE Ø2.0mm L.220mm
• 03701037305614: HUMELOCK STEM HOLDER
• 03701037305607: HUMELOCK SOFT TISSUE HOLDER
• 03701037304785: HUMELOCK II TRIAL STEM T13
• 03701037303672: TRIAL ADAPTER REVERSED 135/145°
• 03701037303665: TRIAL DOUBLE TAPER
• 03701037303658: TRIAL OFFSET HEAD 52x20
• 03701037303641: TRIAL OFFSET HEAD 54x21
• 03701037302941: CORTICAL SCREW TA6V Ø4.5mm L.40mm
• 03701037302934: CORTICAL SCREW TA6V Ø4.5mm L.38mm
• 03701037302804: PROTECTOR + SCREW TA6V
• 03701037301999: CORTICAL SCREW TA6V Ø4.5mm L.32mm
• 03701037301982: CORTICAL SCREW TA6V Ø4.5mm L.30mm
• 03701037301975: CORTICAL SCREW TA6V Ø4.5mm L.28mm
• 03701037301968: CORTICAL SCREW TA6V Ø4.5mm L.26mm
• 03701037301951: CORTICAL SCREW TA6V Ø4.5mm L.24mm
• 03701037301944: CORTICAL SCREW TA6V Ø4.5mm L.22mm
• 03701037301937: CORTICAL SCREW TA6V Ø4.5mm L.20mm
• 03701037301920: CORTICAL SCREW TA6V Ø4.5mm L.18mm
• 03701037301098: HUMELOCK II STEM TA6V SIZE 15 CEMENTLESS TI/HA
• 03701037301081: HUMELOCK II STEM TA6V SIZE 14 CEMENTLESS TI/HA
• 03701037301074: HUMELOCK II STEM TA6V SIZE 13 CEMENTLESS TI/HA
• 03701037301067: HUMELOCK II STEM TA6V SIZE 12 CEMENTLESS TI/HA
• 03701037302019: Humelock II Cementless Shoulder System, CORTICAL SCREW TA6V Ø4.5mm L.36mm
• 03701037302002: CORTICAL SCREW TA6V Ø4.5mm L.34mm
• 03701037301029: HUMELOCK II STEM TA6V SIZE 08 CEMENTLESS TI/HA
• 03701037301043: HUMELOCK II STEM TA6V SIZE 10 CEMENTLESS TI/HA