Performa HS1368

GUDID 05051693301047

Collarless Hip Stem for cemented applications - Size 8 (163 x 16mm) (12/14 Taper)

IMPLANTS INTERNATIONAL LTD

Uncoated femoral stem prosthesis, modular

• Primary Device ID: 05051693301047
• NIH Device Record Key: 7f66e591-e7cd-4e60-bb84-dd0256dd8b0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Performa
• Version Model Number: Collarless Hip Stem - Size 8 (163 x 16mm)
• Catalog Number: HS1368
• 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: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 Millimeter
• Length: 163 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	05051693301047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923898

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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 [Performa]

• 05051693301085: Collarless Hip Stem for cemented applications - Size 6 (165 x 14mm) LONG (12/14 Taper)
• 05051693301078: Collarless Hip Stem for cemented applications - Size 5 (165 x 13mm) LONG (12/14 Taper)
• 05051693301061: Collarless Hip Stem for cemented applications - Size 4 (165 x 12mm) LONG (12/14 Taper)
• 05051693301054: Collarless Hip Stem for cemented applications - Size 3 (165 x 11mm) LONG (12/14 Taper)
• 05051693301047: Collarless Hip Stem for cemented applications - Size 8 (163 x 16mm) (12/14 Taper)
• 05051693301030: Collarless Hip Stem for cemented applications - Size 7 (160 x 15mm) (12/14 Taper)
• 05051693301023: Collarless Hip Stem for cemented applications - Size 6 (156 x 14mm) (12/14 Taper)
• 05051693301016: Collarless Hip Stem for cemented applications - Size 5 (153 x 13mm) (12/14 Taper)
• 05051693301009: Collarless Hip Stem for cemented applications - Size 4 (149 x 12mm) (12/14 Taper)
• 05051693300996: Collarless Hip Stem for cemented applications - Size 3 (146 x 11mm) (12/14 Taper)
• 05051693300989: Collarless Hip Stem for cemented applications - Size 2 (142 x 10mm) (12/14 Taper)
• 05051693300972: Collarless Hip Stem for cemented applications - Size 1 (139 x 9mm) (12/14 Taper)
• 05051693300446: Collared Hip Stem for cemented applications - Size 6 (165 x 14mm) LONG (12/14 Taper)
• 05051693300439: Collared Hip Stem for cemented applications - Size 5 (165 x 13mm) LONG (12/14 Taper)
• 05051693300422: Collared Hip Stem for cemented applications - Size 4 (165 x 12mm) LONG (12/14 Taper)
• 05051693300415: Collared Hip Stem for cemented applications - Size 3-1 (165 x 11mm) LONG (12/14 Taper)
• 05051693300408: Collared Hip Stem for cemented applications - Size 8 (163 x 16mm) (12/14 Taper)
• 05051693300392: Collared Hip Stem for cemented applications - Size 7 (160 x 15mm) (12/14 Taper)
• 05051693300385: Collared Hip Stem for cemented applications - Size 6 (156 x 14mm) (12/14 Taper)
• 05051693300378: Collared Hip Stem for cemented applications - Size 5 (153 x 13mm) (12/14 Taper)
• 05051693300361: Collared Hip Stem for cemented applications - Size 4 (149 x 12mm) (12/14 Taper)
• 05051693300354: Collared Hip Stem for cemented applications - Size 3 (146 x 11mm) (12/14 Taper)
• 05051693300347: Collared Hip Stem for cemented applications - Size 2 (142 x 10mm) (12/14 Taper)
• 05051693300330: Collared Hip Stem for cemented applications - Size 1 (139 x 9mm) (12/14 Taper)