ECHELON 71340519

GUDID 03596010431097

ECHELON 260MM POROUS BOWED FEMORAL COMPONENT¿ANDARD COLLAR¿IZE 19 RIGHT

Smith & Nephew, Inc.

Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular

• Primary Device ID: 03596010431097
• NIH Device Record Key: 3900d3ee-decd-4998-ad6c-58a7f03b7a26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECHELON
• Version Model Number: 71340519
• Catalog Number: 71340519
• Company DUNS: 045483575
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010431097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963486

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: 2023-09-07
• Device Publish Date: 2015-08-30

On-Brand Devices [ECHELON]

• 00885556648759: PROXIMAL REAMER SLEEVE
• 00885556617885: PROXIMAL REAMER SLEEVE
• 00885556278611: ECH PRIM FULLCOAT SZ 19 HIGHOFFSET
• 00885556278567: ECH PRIM FULLCOAT SZ 18 HIGHOFFSET
• 00885556112762: ECHELON TITANIUM PRIMARY STD OFFSET 10-12 TPR S 11
• 00885556112755: ECHELON TITANIUM PRIMARY HIGH OFFSET 10-12 TPR S10
• 00885556056745: ECHELON PRIMARY STEM PC HA STD 12/14 TAPER SZ 17
• 00885556056622: ECHELON PRIMARY STEM PC HA STD 12/14 TAPER SZ 14
• 00885556056370: ECHELON PRIMARY STEM PC HA STD 12/14 TAPER SZ 13
• 00885556056363: ECHELON PRIMARY STEM PC HA HO 12/14 TAPER SZ 15
• 00885556056219: ECHELON PRIMARY STEM PC HA STD 12/14 TAPER SZ 16
• 00885556056141: ECHELON PRIMARY STEM PC HA STD 12/14 TAPER SZ 12
• 00885556056097: ECHELON PRIMARY STEM PC HA HO 12/14 TAPER SZ 14
• 00885556055960: ECHELON PRIMARY STEM PC HA HO 12/14 TAPER SZ 17
• 00885556055922: ECHELON PRIMARY STEM PC HA HO 12/14 TAPER SZ 13
• 00885556055724: ECHELON PRIMARY STEM PC HA STD 12/14 TAPER SZ 15
• 00885556055694: ECHELON PRIMARY STEM PC HA HO 12/14 TAPER SZ 12
• 00885556055502: ECHELON PRIMARY STEM PC HA HO 12/14 TAPER SZ 16
• 00885556052501: ECH HA PC 260MM BWD 15MM CALCAR 17R
• 00885556052495: ECH HA PC 260MM BWD15MM CALCAR 12R
• 00885556052464: ECH HA PC 260MM BWD 15MM CALCAR 20R
• 00885556052440: ECH HA PC 260MM BOWED SZ 13 RT
• 00885556052433: ECH PRM FEM COMP STD 12/14 SZ 17 CLRLS
• 00885556052402: ECH HA PC 260MM BOWED SZ15 LT
• 00885556052396: ECH HA PC 260MM BWD 15MM CALCAR 18L
• 00885556052266: ECH HA PC 260MM BOWED SZ 14 LT
• 00885556052181: ECH HA PC 260MM BWD 15MM CALCAR 19R
• 00885556052136: ECH HA PC 260MM BWD15MM CALCAR 16R
• 00885556052129: ECH HA PC 260MM BWD 15MM CALCAR 14L
• 00885556052112: ECH HA PC 260MM BOWED SZ 18 RT
• 00885556052105: ECH HA PC 260MM BOWED SZ 12 RT
• 00885556052082: ECH PRM FEM COMP HO 12/14 SZ 19 CLRLS
• 00885556052075: ECH HA PC 260MM BWD 15MM CALCAR 17L
• 00885556052068: ECH PRIM FEM COMP STD 12/14 S14 CLRLS
• 00885556052013: ECH HA PC 260MM BWD 15MM CALCAR 13L
• 00885556051917: ECH PRM FEM COMP HO 12/14 SZ 18 CLRLS
• 00885556051863: ECH HA PC 260MM BOWED SZ 19 RT
• 00885556051825: ECH PRIM FEM COMP HO 12/14 S14 CLRLS
• 00885556051818: ECH HA PC 260MM BWD 15MM CALCAR 12L
• 00885556051719: ECH HA PC 260MM BOWED SZ 17 RT
• 00885556051672: ECH HA PC 260MM BOWED SZ 18 LT
• 00885556051627: ECH HA PC 260MM BOWED SZ 20 LT
• 00885556051580: ECH PRIM FEM COMP HO 12/14 S13 CLRLS
• 00885556051450: ECH HA PC 260MM BWD 15MM CALCAR 20L
• 00885556051443: ECH PRIM FEM COMP STD 12/14 S13 CLRLS
• 00885556051351: ECH HA PC 260MM BWD 15MM CALCAR 15R
• 00885556051276: ECH PRM FEM COMP HO 12/14 SZ 17 CLRLS
• 00885556051214: ECH HA PC 260MM BWD 15MM CALCAR 19L
• 00885556051184: ECH PRM FEM COMP STD 12/14 S12 CLRLS
• 00885556051153: ECH HA PC 260MM BOWED SZ 19 LT