RENOVATION 71367555

GUDID 03596010403032

MODULAR STEM EXTRACTOR

Smith & Nephew, Inc.

Knee femur stem prosthesis

• Primary Device ID: 03596010403032
• NIH Device Record Key: b58a2fc4-24e7-4082-9652-397a48ca0d1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENOVATION
• Version Model Number: 71367555
• Catalog Number: 71367555
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
• 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	03596010403032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121714

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

[03596010403032]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-20
• Device Publish Date: 2015-08-30

On-Brand Devices [RENOVATION]

• 07611996146707: SAWBLADE STRYKER 4/5/6/7 13.4/0.4
• 03596010430137: REVERSE CURETTE 7MM
• 03596010430052: REVERSE CURETTE 9MM
• 03596010407177: REVERSE CURETTE 12MM X 17 IN
• 03596010437631: CONICAL TAP 7MM
• 03596010437624: CEMENT DRILL 6MM
• 03596010437471: RENOVATION FEMORAL IMPLANT REMOVAL TRAY INSERT 2
• 03596010437464: RENOVATION FEMORAL IMPLANT REMOVAL TRAY INSERT 1
• 03596010437457: RENOVATION FEMORAL IMPLANT REMOVAL TRAY
• 03596010437440: RENOVATION ACETABULAR IMPLANT TRAY REMOVAL INSERT
• 03596010437433: RENOVATION ACETABULAR IMPLANT REMOVAL TRAY
• 03596010427588: ANGLED GOUGE
• 03596010407207: X OSTEOTOME 7MM X 17 IN
• 03596010407191: CARBIDE PUNCH
• 03596010407184: CHISEL 8MM X 17 IN
• 03596010403063: FIXED HEAD STEM EXTRACTOR
• 03596010403056: HOOK STEM EXTRACTOR
• 03596010403049: T-HANDLE WRENCH
• 03596010403032: MODULAR STEM EXTRACTOR
• 03596010403025: LARGE SLAP HAMMER
• 03596010403018: SLOTTED MALLET
• 03596010402974: THIN OSTEOTOME BLADE 8MM X 5 IN
• 03596010402967: THIN OSTEOTOME BLADE 10MM X 5 IN
• 03596010402950: THIN OSTEO BLD ROUND END 20MM
• 03596010402943: THIN OSTEOTOME BLADE ROUNDED END 20MM
• 03596010402936: THIN OSTEOTOME BLADE 20MM X 3 IN
• 03596010402929: THIN OSTEOTOME BLADE 12MM X 3 IN
• 03596010402912: THIN OSTEOTOME BLADE 10MM X 3 IN
• 03596010402905: THIN OSTEOTOME BLADE 8MM X 3 IN
• 03596010402899: RADIAL OSTEOTOME BLADE SIZE 16
• 03596010402882: RADIAL OSTEOTOME BLADE SIZE 14
• 03596010402875: RADIAL OSTEOTOME BLADE SIZE 12
• 03596010402868: RADIAL OSTEOTOME BLADE SIZE 10
• 03596010402776: ROUND ACETABULAR CEMENT SPLITTER
• 03596010402769: CURVED ACETABULAR CHISEL
• 03596010402752: ACETABULAR COMPONENT FORCEPS
• 03596010402745: ACETABULAR COMPONENT GRIPPER
• 03596010402738: SMALL SLAP HAMMER
• 03596010402721: OSTEOTOME SYSTEM TRAY INSERT
• 03596010403100: RENOVATION CEMENT DRILL 8MM
• 03596010403087: RENOVATION CONICAL TAP 11MM
• 03596010403094: CONICAL TAP 13MM
• 03596010403070: CONICAL TAP 9MM
• 03596010437617: CEMENT DRILL 4.5MM
• 03596010406415: RONGEUR 300MM WITH TEETH
• 03596010406408: RONGEUR 200MM WITH TEETH
• 03596010406392: STRAIGHT GOUGE
• 03596010406378: FLAG SPLITTER
• 03596010403131: V SPLITTER
• 03596010402851: SMALL ACETABULAR GOUGE