POLARCUPTM 75017194

GUDID 07611996096170

POLARCUP SHELL 43 CEMENTED

Smith & Nephew, Inc.

Acetabular shell

• Primary Device ID: 07611996096170
• NIH Device Record Key: 1148a91a-a887-4515-859c-0b3cdba19e51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLARCUPTM
• Version Model Number: 75017194
• Catalog Number: 75017194
• 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	07611996096170 [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