RIGI-FIX Series II HS1453

GUDID 05051693301214

Uncemented Hip Stem for Press Fit Applications - Size 1 (128 x 5mm) (12/14 Taper)

IMPLANTS INTERNATIONAL LTD

Coated hip femur prosthesis, modular

• Primary Device ID: 05051693301214
• NIH Device Record Key: 2b88263e-bbd1-43e2-a62c-a587719863ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIGI-FIX Series II
• Version Model Number: Uncemented Hip Stem - Size 1 (128 x 5mm)
• Catalog Number: HS1453
• Company DUNS: 346627222
• Company Name: IMPLANTS INTERNATIONAL LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401642769080
• Email: michael.russon@implantsinterna
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com

Device Dimensions

• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter
• Length: 128 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature and Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051693301214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072101

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-31

On-Brand Devices [RIGI-FIX Series II]

• 05051693301306: Uncemented Hip Stem for Press Fit Applications - Size 10 (158 x 17.5mm) (12/14 Taper)
• 05051693301290: Uncemented Hip Stem for Press Fit Applications - Size 9 (152 x 15mm) (12/14 Taper)
• 05051693301283: Uncemented Hip Stem for Press Fit Applications - Size 8 (149 x 13.75mm) (12/14 Taper)
• 05051693301276: Uncemented Hip Stem for Press Fit Applications - Size 7 (146 x 12.5mm) (12/14 Taper)
• 05051693301269: Uncemented Hip Stem for Press Fit Applications - Size 6 (143 x 11.25mm) (12/14 Taper)
• 05051693301252: Uncemented Hip Stem for Press Fit Applications - Size 5 (140 x 10mm) (12/14 Taper)
• 05051693301245: Uncemented Hip Stem for Press Fit Applications - Size 4 (137 x 9mm) (12/14 Taper)
• 05051693301238: Uncemented Hip Stem for Press Fit Applications - Size 3 (134 x 7.5mm) (12/14 Taper)
• 05051693301221: Uncemented Hip Stem for Press Fit Applications - Size 2 (130 x 6.2mm) (12/14 Taper)
• 05051693301214: Uncemented Hip Stem for Press Fit Applications - Size 1 (128 x 5mm) (12/14 Taper)