POLARCUPTM 75017191

GUDID 07611996096149

POLARCUP SHELL TI-PLASMA 63 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 Acetabular shell Acetabular shell Acetabular shell

• Primary Device ID: 07611996096149
• NIH Device Record Key: 82170c05-9b1a-4832-98bd-c5871f796529
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLARCUPTM
• Version Model Number: 75017191
• Catalog Number: 75017191
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• 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	07611996096149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070278

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or 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: 3
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

On-Brand Devices [POLARCUPTM]

• 07611996118520: POLARCUP SHELL 63 CEMENTED
• 07611996118513: POLARCUP SHELL 61 CEMENTED
• 07611996118506: POLARCUP SHELL 59 CEMENTED
• 07611996118490: POLARCUP SHELL 57 CEMENTED
• 07611996118483: POLARCUP SHELL 55 CEMENTED
• 07611996118476: POLARCUP SHELL 53 CEMENTED
• 07611996118469: POLARCUP SHELL 51 CEMENTED
• 07611996118452: POLARCUP SHELL 49 CEMENTED
• 07611996118445: POLARCUP SHELL 47 CEMENTED
• 07611996118438: POLARCUP SHELL 45 CEMENTED
• 07611996118421: POLARCUP SHELL 43 CEMENTED
• 07611996118087: POLARCUP SHELL TI-PLASMA 65 NON-CEM
• 07611996118025: POLARCUP SHELL TI-PLASMA 53 NON-CEM
• 07611996118018: POLARCUP SHELL TI-PLASMA 51 NON-CEM
• 07611996118001: POLARCUP SHELL TI-PLASMA 49 NON-CEM
• 07611996117998: POLARCUP SHELL TI-PLASMA 47 NON-CEM
• 07611996111545: POLARCUP XLPE INSERT 65/28 NON-CEM
• 07611996111491: POLARCUP XLPE INSERT 55/28 NON-CEM
• 07611996111484: POLARCUP XLPE INSERT 53/28 NON-CEM
• 07611996111477: POLARCUP XLPE INSERT 51/28 NON-CEM
• 07611996111460: POLARCUP XLPE INSERT 49/28 NON-CEM
• 07611996111453: POLARCUP XLPE INSERT 47/28 NON-CEM
• 07611996096644: POLARCUP CORTICAL SCREW 4.5X60 NON CEM
• 07611996096637: POLARCUP CORTICAL SCREW 4.5X55 NON CEM
• 07611996096620: POLARCUP CORTICAL SCREW 4.5X52 NON CEM
• 07611996096613: POLARCUP CORTICAL SCREW 4.5X48 NON CEM
• 07611996096606: POLARCUP CORTICAL SCREW 4.5X44 NON CEM
• 07611996096590: POLARCUP CORTICAL SCREW 4.5X40 NON CEM
• 07611996096576: POLARCUP ANCHORING PEG (2 EACH)
• 07611996096552: POLARCUP PE INSERT 67/28 NON-CEM
• 07611996096545: POLARCUP PE INSERT 65/28 NON-CEM
• 07611996096538: POLARCUP PE INSERT 63/28 NON-CEM
• 07611996096521: POLARCUP PE INSERT 61/28 NON-CEM
• 07611996096514: POLARCUP PE INSERT 59/28 NON-CEM
• 07611996096507: POLARCUP PE INSERT 57/28 NON-CEM
• 07611996096491: POLARCUP PE INSERT 55/28 NON-CEM
• 07611996096484: POLARCUP PE INSERT 53/28 NON-CEM
• 07611996096477: POLARCUP PE INSERT 51/28 NON-CEM
• 07611996096460: POLARCUP PE INSERT 49/28 NON-CEM
• 07611996096453: POLARCUP PE INSERT 47/28 NON-CEM
• 07611996096323: POLARCUP PE INSERT 45/22 NON-CEM
• 07611996096316: POLARCUP PE INSERT 43/22 NON-CEM
• 07611996096279: POLARCUP SHELL 63 CEMENTED
• 07611996096262: POLARCUP SHELL 61 CEMENTED
• 07611996096255: POLARCUP SHELL 59 CEMENTED
• 07611996096248: POLARCUP SHELL 57 CEMENTED
• 07611996096231: POLARCUP SHELL 55 CEMENTED
• 07611996096224: POLARCUP SHELL 53 CEMENTED
• 07611996096217: POLARCUP SHELL 51 CEMENTED
• 07611996096200: POLARCUP SHELL 49 CEMENTED