Total Foot System 2 2802108

GUDID 00885556838150

INTERPOSITIONING PLATE. 8MM STEM

Smith & Nephew, Inc.

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 00885556838150
• NIH Device Record Key: d634e6b8-0735-4d25-b56c-ba6d40602449
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Foot System 2
• Version Model Number: 2802108
• Catalog Number: 2802108
• 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: 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)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
• 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	00885556838150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100502

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

[00885556838150]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-18
• Device Publish Date: 2022-12-22

On-Brand Devices [Total Foot System 2]

• 00885556839935: TX 8 DRIVER. NON-CANNULATED W/AO
• 00885556839881: MODIFIED MINI JANSEN RETRACTORS
• 00885556839867: MPJ 1.8MM INTERFRAG DRILL GUIDE RIGHT
• 00885556839850: REARFOOT DISTRACTION GAUGE
• 00885556839843: TFS PLATE BENDER HANDLE ASSY. SMALL
• 00885556839836: TFS PLATE BENDER HANDLE ASSY. LARGE
• 00885556839829: MPJ 1.8MM INTERFRAG DRILL GUIDE LEFT
• 00885556839812: 2.5MM LOCKING DRILL GUIDE (YELLOW)
• 00885556839799: K-WIRE DISTRACTION/COMPRESSION FORCEPS
• 00885556839782: 2.5MM HEX DRIVER. NON-CANNULATED W/AO
• 00885556839775: FOREFOOT DISTRACTION GAUGE
• 00885556837849: DOUBLE DRILL GUIDE HANDLE
• 00885556828106: PLATE BENDING IRON
• 00885556828069: CUP & CONE CADDY LID
• 00885556828052: CONE SPHERICAL REAMER SZ. 24MM
• 00885556828045: CONE SPHERICAL REAMER SZ. 21MM
• 00885556828038: CONE SPHERICAL REAMER SZ. 19MM
• 00885556828021: CONE SPHERICAL REAMER SZ. 16MM
• 00885556828014: CUP SPHERICAL REAMER SZ. 24MM
• 00885556828007: CUP SPHERICAL REAMER SZ. 21MM
• 00885556827994: CUP SPHERICAL REAMER SZ. 19MM
• 00885556827987: CUP SPHERICAL REAMER SZ. 16MM
• 00885556838990: OPEN WEDGE PLATE STEM SZ. 6MM
• 00885556838983: OPEN WEDGE PLATE STEM SZ. 5MM
• 00885556838976: OPEN WEDGE PLATE STEM SZ. 4MM
• 00885556838969: OPEN WEDGE PLATE STEM SZ. 3MM
• 00885556838952: OPEN WEDGE PLATE STEM SZ. 2MM
• 00885556838945: OPEN WEDGE PLATE STEM SZ. 0MM
• 00885556838327: TARSALIS PLATE 10 HOLE STRAIGHT
• 00885556838310: TARSALIS PLATE 3 HOLE STRAIGHT LONG
• 00885556838297: TARSALIS PLATE 2 HOLE STRAIGHT SHORT
• 00885556838259: MPJ FUSION PLATE LONG RIGHT
• 00885556838228: MPJ FUSION PLATE MEDIUM LEFT
• 00885556838211: CALCANEUS PLATE SZ. MINI-LONG
• 00885556838303: TARSALIS PLATE 2 HOLE STRAIGHT LONG
• 00885556838242: MPJ FUSION PLATE LONG LEFT
• 00885556838235: MPJ FUSION PLATE MEDIUM RIGHT
• 00885556838204: CALCANEUS PLATE SZ. MINI
• 00885556837870: OLIVE WIRE 1.1MM DIA. X 100MM
• 00885556837993: FOREFOOT UNIVERSAL PLATE. 18MM
• 00885556837986: FOREFOOT UNIVERSAL PLATE. 16MM
• 00885556837979: FOREFOOT UNIVERSAL PLATE. 14MM
• 00885556839027: OPEN WEDGE PLATE. 4.5MM
• 00885556839010: OPEN WEDGE PLATE. 3.5MM
• 00885556839003: OPEN WEDGE PLATE. 2.5MM
• 00885556838433: TARSALIS PLATE. 8-HOLE T SHAPE RIGHT
• 00885556838426: TARSALIS PLATE. 7-HOLE T SHAPE RIGHT
• 00885556838419: TARSALIS PLATE. 6-HOLE T SHAPE STRAIGHT
• 00885556838396: TARSALIS PLATE. 4-HOLE STRAIGHT
• 00885556838341: TARSALIS PLATE. 4-HOLE T SHAPE STRAIGHT