REFLECTION 71332054

GUDID 00885556021002

REFLECTION FSO5 CERAMIC ACETABULAR COMPONENT 54MM

Smith & Nephew, Inc.

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell

• Primary Device ID: 00885556021002
• NIH Device Record Key: 38b8a39b-bb37-4a3d-8d49-2125b883ecb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REFLECTION
• Version Model Number: 71332054
• Catalog Number: 71332054
• 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: 1-800-238-7538
• 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	00885556021002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030022

FDA Product Code

• MRA: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, 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: 2018-07-06
• Device Publish Date: 2015-05-06

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