PROMOS 75006720

GUDID 07611996083842

PROMOS MONOBLOCK STEM 02/35MM NON-CEM

Smith & Nephew, Inc.

Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis

• Primary Device ID: 07611996083842
• NIH Device Record Key: 5202adef-3bbe-462d-9ac7-1112a8c65aa8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROMOS
• Version Model Number: 75006720
• Catalog Number: 75006720
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611996083842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063578

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC 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 [PROMOS]

• 00885556654897: PROMOS REVERSE BODY DIAMETER 36/21MM
• 00885556654880: PROMOS REVERSE BODY DIAMETER 36/18MM
• 07612883015922: VKS/PROMOS RESECTION STYLUS
• 07611996127225: SLEEVE/HEAD IMPACTOR
• 07611996127218: HOLDING FORK
• 07611996127201: SLEEVE ALIGNMENT GUIDE
• 07611996127195: PRIMARY ALIGNMENT GUIDE
• 07611996120554: PLUS PROMOS INCLINATION SET 26MM
• 07611996120547: PLUS PROMOS INCLINATION SET 24MM
• 07611996120530: PLUS PROMOS INCLINATION SET 22MM
• 07611996120523: PLUS PROMOS INCLINATION SET 20MM
• 07611996117738: PROMOS REVERSE GLENOID DRILL DIA4
• 07611996115543: PROMOS INSERTER 5
• 07611996115529: PROMOS RASP STEM 5
• 07611996115390: PROMOS TRIAL HUMERAL STEM 5
• 07611996114539: PROMOS SCREW REMOVER OLD STANDARD BODY SW3.5
• 07611996114522: PROMOS SCREW REMOVER T25
• 07611996112641: PROMOS REV SCREW LOOSENING ADAP GLENO
• 07611996112139: PROMOS RELEASE CLAMP
• 07611996112122: PROMOS RELEASE ADAPTER GLENOSPHERE
• 07611996111262: PROMOS REVERSE CUTTING ADAPTER RIGHT
• 07611996111255: PROMOS REVERSE CUTTING ADAPTER LEFT
• 07611996111248: PROMOS REV TRIAL FIXATION SCREW INSERTER
• 07611996111231: PROMOS REVERSE ORIENTATION DEVICE DIA42
• 07611996111224: PROMOS REVERSE ORIENTATION DEVICE DIA36
• 07611996111217: PROMOS REVERSE REAMER GUIDE FIXAT.DEVICE
• 07611996111200: PROMOS REV TRIAL GLENOSPHERE CENTRIC DIA42
• 07611996111194: PROMOS REV TRIAL GLENOSPHERE CENTRIC DIA36
• 07611996111156: PROMOS REVERSE ORIENTATION PIN
• 07611996111149: PROMOS REVERSE CUTTING DEVICE
• 07611996111132: PROMOS REV GLENOSPHERE PERIPHERAL REAMER
• 07611996111125: PROMOS REV TRIAL GLENOSPHERE ECCENTR. DIA42
• 07611996111118: PROMOS REV TRIAL GLENOSPHERE ECCENTR. DIA36
• 07611996111101: PROMOS REVERSE GLENOSPHERE DRILL GUIDE
• 07611996111095: PROMOS REVERSE ADAPT.GLENOSPHERE ECCENTR
• 07611996111088: PROMOS REVERSE ADAPT.GLENOSPHERE CENTRIC
• 07611996111071: PROMOS REVERSE FIXATION SCREW INSERTER
• 07611996111064: PROMOS REVERSE INSERTER
• 07611996109597: PROMOS DRILL SLEEVE 4
• 07611996109573: PROMOS DRIVE SHAFT
• 07611996109566: PROMOS GUIDE WIRE DIA3
• 07611996092196: PROMOS CASE 6 PROXIMAL STANDARD
• 07611996092189: PROMOS CASE 5 PROXIMAL STANDARD
• 07611996092172: PROMOS CASE 4 STEM STANDARD/REVERSE
• 07611996092165: PROMOS CASE 3 STEM STANDARD/REVERSE
• 07611996092141: PROMOS CASE 7 EXTRACTOR STANDARD/REVERSE
• 07611996092134: PROMOS TRAY 5+6 PROXIMAL STANDARD
• 07611996092127: PROMOS CASE 5+6 PROXIMAL STANDARD
• 07611996092110: PROMOS TRAY 3+4 STEM STANDARD/REVERSE
• 07611996092097: PROMOS CASE 2 GLENOID STANDARD