REFLECTION 71336460

GUDID 03596010454393

REFLECTION THREE HOLE SHELL SIZE 60MM

Smith & Nephew, Inc.

Acetabular shell

• Primary Device ID: 03596010454393
• NIH Device Record Key: 0f9ace19-a7ac-4c93-84ab-f1aa803fc409
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REFLECTION
• Version Model Number: 71336460
• Catalog Number: 71336460
• 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)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	03596010454393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211176
• Premarket Notification: K960094

FDA Product Code

• MBL: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous

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: 2015-08-30

On-Brand Devices [REFLECTION]

• 00885556689837: REFLECTION CUP POSITIONER / IMPACTOR
• 00885556669471: SHELL INSERTER FOR REFLECTION
• 00885556651322: REFLECTION SHELL IMPACTOR
• 00885556624524: 45 DEGREE DRILL GUIDE
• 00885556623558: 45 DEGREE DRILL GUIDE
• 00885556577165: SYNCERA REFLECTION NEUTRAL TRIAL LINER TRAY
• 00885556493908: SYNCERA REFLECTION TRIAL SHELL TRAY
• 00885556281994: REFLECTION XLPE 40ID 20 DEGREE 66-68OD SIZE J
• 00885556281949: REFLECTION XLPE 40ID 20 DEGREE 62-64OD SIZE H
• 00885556281895: REFLECTION XLPE 40ID +4 20 DEGREE 58-60OD SIZE G
• 00885556052587: REFL THREADED MULTI HOLE PC ACET 64 W/LOCK SCREWS
• 00885556052389: 35MM LOCKING HEAD SCREW
• 00885556052341: REFL THREADED MULTI HOLE PC ACET 62 W/LOCK SCREWS
• 00885556051979: REFL THREADED MULTI HOLE PC ACET 54 W/LOCK SCREWS
• 00885556051795: REFL THREADED MULTI HOLE PC ACET 52 W/LOCK SCREWS
• 00885556051740: REFL THREADED MULTI HOLE PC ACET 60 W/LOCK SCREWS
• 00885556051399: REFL THREADED MULTI HOLE PC ACET 50 W/LOCK SCREWS
• 00885556051085: 20MM LOCKING HEAD SCREW
• 00885556050910: REFL THREADED MULTI HOLE PC ACET 58 W/LOCK SCREWS
• 00885556050217: 15MM LOCKING HEAD SCREW
• 00885556050163: REFL THREADED MULTI HOLE PC ACET 56 W/LOCK SCREWS
• 00885556049693: REFL ACET FLEX DR W/TRINKLE END
• 00885556043554: REFL LINER 32MM ID X 56/56MM OD 20 DEGREE +4
• 00885556043431: REFLECTION ACETABULAR FIXATION PEG 25mm
• 00885556042434: REFLECTION FINNED POROUS ACETABULAR SHELL 60mm OD
• 00885556029695: REFLECTION 28 35 50-52 TRIAL LINER
• 00885556028773: REFLECTION 36 35 58-60 TRIAL LINER
• 00885556028681: REFLECTION 35 DEG TRIAL LINER TRAY
• 00885556028667: REFLECTION 28 35 46-48 TRIAL LINER
• 00885556028384: REFLECTION 20 DEG +4 TRIAL LINER TRAY
• 00885556028209: REFLECTION 32 35 62-64 TRIAL LINER
• 00885556027752: REFLECTION TRIAL LINER 0 DEGREE 36MM 70-76 SZ K
• 00885556027400: REFLECTION 36 35 70-76 TRIAL LINER
• 00885556027394: REFLECTION 32 35 58-60 TRIAL LINER
• 00885556027202: REFLECTION 36 35 66-68 TRIAL LINER
• 00885556026953: REFLECTION 32 35 54-56 TRIAL LINER
• 00885556026915: REFLECTION 36 35 62-64 TRIAL LINER
• 00885556026793: REFLECTION TRIAL LINER 0 DEGREE 26MM 54-56 OUTER DIAMETER
• 00885556026656: REFLECTION TRIAL LINER 20 DEGREE 26MM 50-52 OUTER DIAMETER
• 00885556026540: REFLECTION TRIAL 22MM ANT +4 70-76MM SZ K
• 00885556026472: REFLECTION TRIAL LINER 20 DEGREE 26MM 70-76OD
• 00885556026397: REFLECTION TRIAL 22MM ANT +4 66-68MM SZ J
• 00885556026304: REFLECTION TRIAL LINER 20 DEGREE 26MM 54-56 OUTER DIAMETER
• 00885556026298: REFLECTION TRIAL LINER 0 DEGREE 26MM 46-48 OUTER DIAMETER
• 00885556026250: REFL TRIAL LNR 26MM LATERALIZED +4 66-68MM OD SZ J
• 00885556026168: REFLECTION TRIAL LINER 0 DEGREE 26MM 58-60 OUTER DIAMETER
• 00885556026137: REFLECTION TRIAL LINER 0 DEGREE 22MM 62-64 OUTER DIAMETER
• 00885556026106: REFLECTION TRIAL LINER 0 DEGREE 22MM 54-56 OUTER DIAMETER
• 00885556026007: REFLECTION TRIAL 26MM ANT +4 70-76MM SZ K
• 00885556025994: REFLECTION TRIAL LINER 0 DEGREE 22MM 46-48OD