SYNERGY 71306715

GUDID 03596010194596

SYN HA PF FEM COMP SZ 15

Smith & Nephew, Inc.

Ceramic femoral head prosthesis

• Primary Device ID: 03596010194596
• NIH Device Record Key: 26fe7216-40c1-45b4-91df-e842a81c3ffe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNERGY
• Version Model Number: 71306715
• Catalog Number: 71306715
• 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)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	03596010194596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211176
• Premarket Notification: K970337

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [SYNERGY]

• 00885556739952: TRIAL FEM HEAD WITH HOLES 32MM -3MM
• 00885556737774: TRIAL FEM HEAD WITH HOLES 32MM -3MM
• 00885556737651: TRIAL HEAD WITH TAPER 36MM -3
• 00885556737644: TRIAL HEAD WITH TAPER 36MM +12
• 00885556737637: TRIAL HEAD WITH TAPER 36MM +8
• 00885556737620: TRIAL HEAD WITH TAPER 36MM +4
• 00885556737613: TRIAL HEAD WITH TAPER 36MM +0
• 00885556736401: FULLY TOOTHED BROACH OVERSIZED 18
• 00885556736395: FULLY TOOTHED BROACH OVERSIZED 17
• 00885556736388: FULLY TOOTHED BROACH OVERSIZED 16
• 00885556736371: FULLY TOOTHED BROACH OVERSIZED 15
• 00885556736364: FULLY TOOTHED BROACH OVERSIZED 14
• 00885556736357: FULLY TOOTHED BROACH OVERSIZED 13
• 00885556736340: FULLY TOOTHED BROACH OVERSIZED 12
• 00885556736333: FULLY TOOTHED BROACH OVERSIZED 11
• 00885556736326: FULLY TOOTHED BROACH OVERSIZED 10
• 00885556736319: FULLY TOOTHED BROACH OVERSIZED 9
• 00885556730423: MODIFIED SYNERGY BROACH SZ 18
• 00885556730416: MODIFIED SYNERGY BROACH SZ 17
• 00885556730409: MODIFIED SYNERGY BROACH SZ 16
• 00885556730393: MODIFIED SYNERGY BROACH SZ 15
• 00885556730386: MODIFIED SYNERGY BROACH SZ 14
• 00885556730379: MODIFIED SYNERGY BROACH SZ 13
• 00885556730362: MODIFIED SYNERGY BROACH SZ 12
• 00885556730355: MODIFIED SYNERGY BROACH SZ 11
• 00885556730348: MODIFIED SYNERGY BROACH SZ 10
• 00885556730331: MODIFIED SYNERGY BROACH SZ 9
• 00885556730324: MODIFIED SYNERGY BROACH SZ 8
• 00885556721148: FULLY TOOTHED BROACH OVERSIZED 18
• 00885556721131: FULLY TOOTHED BROACH OVERSIZED 17
• 00885556721124: FULLY TOOTHED BROACH OVERSIZED 16
• 00885556721117: FULLY TOOTHED BROACH OVERSIZED 15
• 00885556721100: FULLY TOOTHED BROACH OVERSIZED 14
• 00885556721094: FULLY TOOTHED BROACH OVERSIZED 13
• 00885556721087: FULLY TOOTHED BROACH OVERSIZED 12
• 00885556721070: FULLY TOOTHED BROACH OVERSIZED 11
• 00885556721063: FULLY TOOTHED BROACH OVERSIZED 10
• 00885556721056: FULLY TOOTHED BROACH OVERSIZED 9
• 00885556715543: HIP INSERTER
• 00885556714898: FULLY TOOTHED BROACH OVERSIZED 18
• 00885556714881: FULLY TOOTHED BROACH OVERSIZED 17
• 00885556714874: FULLY TOOTHED BROACH OVERSIZED 16
• 00885556714867: FULLY TOOTHED BROACH OVERSIZED 15
• 00885556714850: FULLY TOOTHED BROACH OVERSIZED 14
• 00885556714843: FULLY TOOTHED BROACH OVERSIZED 13
• 00885556714836: FULLY TOOTHED BROACH OVERSIZED 12
• 00885556714829: FULLY TOOTHED BROACH OVERSIZED 11
• 00885556714812: FULLY TOOTHED BROACH OVERSIZED 10
• 00885556714805: FULLY TOOTHED BROACH OVERSIZED 9
• 00885556696798: TRIAL FEM HEAD WITH HOLES - 32MM +8