OPTI-FIX 71337850

GUDID 00885556021910

OPTIFIX XLPE ANTVTD 28 +4 50-54

Smith & Nephew, Inc.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00885556021910
• NIH Device Record Key: 3a9c71ea-7139-45e3-a087-dc73c5f7339a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTI-FIX
• Version Model Number: 71337850
• Catalog Number: 71337850
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556021910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864857

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

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 [OPTI-FIX]

• 00885556028858: OPTIFIX 32 56-62 ANTVTD +4 TRIAL LINER
• 00885556027448: OPTIFIX 32 63-74 ANTVTD +4 TRIAL LINER
• 00885556027424: OPTIFIX 36 63-74 ANTVTD +4 TRIAL LINER
• 00885556027226: OPTIFIX 28 56-62 ANTVTD +4 TRIAL LINER
• 00885556027042: OPTIFIX 26 46-48 ANTVTD +4 TRIAL LINER
• 00885556026946: OPTIFIX 28 50-54 ANTVTD +4 TRIAL LINER
• 00885556021910: OPTIFIX XLPE ANTVTD 28 +4 50-54
• 00885556021637: OPTIFIX XLPE ANTVTD 32 +4 63-74
• 00885556021590: OPTI-FIX XLPE 28MM ID 20 DEGREE 63-74 OD LINER
• 00885556021439: OPTI-FIX XLPE 22MM ID 20 DEGREE 46-48 OD LINER
• 00885556021231: OPTIFIX XLPE ANTVTD 32 +4 56-62
• 00885556021026: OPTI-FIX XLPE 22MM ID 20 DEGREE 44-45 OD LINER
• 00885556021019: OPTI-FIX XLPE 28MM ID 20 DEGREE 56-62 OD LINER
• 00885556020913: OPTIFIX XLPE ANTVTD 36 +4 63-74
• 00885556020388: OPTI-FIX XLPE 26MM ID 20 DEGREE 50-54 OD LINER
• 00885556020265: OPTI-FIX XLPE 32MM ID 20 DEGREE 63-74 OD LINER
• 00885556020043: OPTIFIX XLPE ANTVTD 26 +4 46-48
• 00885556020036: OPTIFIX XLPE ANTVTD 28 +4 56-62
• 00885556019955: OPTI-FIX XLPE 26MM ID 20 DEGREE 46-48 OD LINER
• 00885556019917: OPTI-FIX XLPE 32MM ID 20 DEGREE 56-62 OD LINER
• 03596010514059: OPTI-FIX XLPE 28MM ID 20 DEGREE 50-54 OD LINER
• 03596010124814: OPTI-FIX ACETABULAR DRILL GUIDE