POLARCUP 75100444

GUDID 07611996118353

POLARCUP SHELL TI-PLASMA/HA 59 NON-CEM

Smith & Nephew, Inc.

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell

• Primary Device ID: 07611996118353
• NIH Device Record Key: 212cace2-cb18-4660-b66b-9636b1c8abeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLARCUP
• Version Model Number: 75100444
• Catalog Number: 75100444
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611996118353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122244

FDA Product Code

• LWJ: Prosthesis, hip, semi-constrained, metal/polymer, 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: 2015-11-25

On-Brand Devices [POLARCUP]

• 00885556701294: TANDEM STYLE POLAR CUP TRIAL LINER 67/28
• 00885556701287: TANDEM STYLE POLAR CUP TRIAL LINER 65/28
• 00885556701270: TANDEM STYLE POLAR CUP TRIAL LINER 63/28
• 00885556701263: TANDEM STYLE POLAR CUP TRIAL LINER 61/28
• 00885556701256: TANDEM STYLE POLAR CUP TRIAL LINER 59/28
• 00885556701249: TANDEM STYLE POLAR CUP TRIAL LINER 57/28
• 00885556701232: TANDEM STYLE POLAR CUP TRIAL LINER 55/28
• 00885556701225: TANDEM STYLE POLAR CUP TRIAL LINER 53/28
• 00885556701218: TANDEM STYLE POLAR CUP TRIAL LINER 51/28
• 00885556701201: TANDEM STYLE POLAR CUP TRIAL LINER 49/28
• 00885556701195: TANDEM STYLE POLAR CUP TRIAL LINER 47/28
• 00885556701188: TANDEM STYLE POLAR CUP TRIAL LINER 45/28
• 00885556701171: TANDEM STYLE POLAR CUP TRIAL LINER 43/28
• 07611996118988: BASIC CASE II POLARCUP 10
• 07611996118971: BASIC CASE I POLARCUP 10
• 07611996118964: CASE ACCESSORIES POLARCUP 10
• 07611996118957: CASE NAV POLARCUP 10
• 07611996118391: POLARCUP SHELL TI-PLASMA/HA 67 NON-CEM
• 07611996118384: POLARCUP SHELL TI-PLASMA/HA 65 NON-CEM
• 07611996118377: POLARCUP SHELL TI-PLASMA/HA 63 NON-CEM
• 07611996118360: POLARCUP SHELL TI-PLASMA/HA 61 NON-CEM
• 07611996118353: POLARCUP SHELL TI-PLASMA/HA 59 NON-CEM
• 07611996118346: POLARCUP SHELL TI-PLASMA/HA 57 NON-CEM
• 07611996118339: POLARCUP SHELL TI-PLASMA/HA 55 NON-CEM
• 07611996118322: POLARCUP SHELL TI-PLASMA/HA 53 NON-CEM
• 07611996118315: POLARCUP SHELL TI-PLASMA/HA 51 NON-CEM
• 07611996118308: POLARCUP SHELL TI-PLASMA/HA 49 NON-CEM
• 07611996118292: POLARCUP SHELL TI-PLASMA/HA 47 NON-CEM
• 07611996118285: POLARCUP SHELL TI-PLASMA/HA 45 NON-CEM
• 07611996118278: POLARCUP SHELL TI-PLASMA/HA 43 NON-CEM
• 07611996118094: POLARCUP SHELL TI-PLASMA 67 NON-CEM
• 07611996118070: POLARCUP SHELL TI-PLASMA 63 NON-CEM
• 07611996118063: POLARCUP SHELL TI-PLASMA 61 NON-CEM
• 07611996118056: POLARCUP SHELL TI-PLASMA 59 NON-CEM
• 07611996118049: POLARCUP SHELL TI-PLASMA 57 NON-CEM
• 07611996118032: POLARCUP SHELL TI-PLASMA 55 NON-CEM
• 07611996117981: POLARCUP SHELL TI-PLASMA 45 NON-CEM
• 07611996117974: POLARCUP SHELL TI-PLASMA 43 NON-CEM
• 07611996116885: POLARCUP TRIAL INSERT SLOTTED 28/67
• 07611996116878: POLARCUP TRIAL INSERT SLOTTED 28/65
• 07611996116861: POLARCUP TRIAL INSERT SLOTTED 28/63
• 07611996116854: POLARCUP TRIAL INSERT SLOTTED 28/61
• 07611996116847: POLARCUP TRIAL INSERT SLOTTED 28/59
• 07611996116830: POLARCUP TRIAL INSERT SLOTTED 28/57
• 07611996116823: POLARCUP TRIAL INSERT SLOTTED 28/55
• 07611996116816: POLARCUP TRIAL INSERT SLOTTED 28/53
• 07611996116809: POLARCUP TRIAL INSERT SLOTTED 28/51
• 07611996116793: POLARCUP TRIAL INSERT SLOTTED 28/49
• 07611996116786: POLARCUP TRIAL INSERT SLOTTED 28/47
• 07611996116779: POLARCUP TRIAL INSERT SLOTTED 22/67